Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT04854499
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in patients with head and neck squamous cell carcinoma (HNSCC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 193
- Histologically or cytologically confirmed metastatic or locally recurrent HNSCC that is considered incurable by local therapies.
Safety Run-in Cohort 1 and Phase 2 Cohorts 1
- Should not have had prior systemic therapy administered in the recurrent or metastatic setting.
- Eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and larynx. Nasopharynx is not included.
- HNSCC per protocol specified inclusion criteria regardless of PD-L1 status.
Safety Run-in Cohort 2 and Phase 2 Cohort 3
- Histologically or cytologically confirmed locally advanced/mHNSCC regardless of PD-L1 status with at least 1 and no more than 2 lines of prior systemic anticancer therapy in the locally advanced/metastatic setting.
Key
- Active central nervous system (CNS) disease (individuals with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active).
- History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
- Progressive disease within 6 months of completion of curatively intended treatment for locally advanced/mHNSCC.
Safety Run-in Cohort 1, Pre-expansion Safety Run-in Cohort for Magrolimab + Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2
-
Prior treatment with any of the following:
- Anti-programmed cell death protein 1 or anti-PD-L1 checkpoint inhibitors.
- Anti-cytotoxic T-lymphocyte-associated protein 4 checkpoint inhibitors.
Safety Run-in Cohort 2 and Phase 2 Cohort 3
- Prior treatment with a taxane.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum Pembrolizumab Participants with untreated metastatic or unresectable, locally recurrent head and neck squamous cell carcinoma (HNSCC) regardless of programmed cell death ligand 1 (PD-L1) status will receive the following: * magrolimab * pembrolizumab 200 mg on Day 1 of each cycle * 5-fluorouracil (5-FU) 1000 mg/m\^2/day Days 1-4 of each cycle (for up to 6 cycles) * platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin area under the concentration versus time curve (AUC) 5 per investigator choice (for up to 6 cycles)) Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the recommended Phase 2 dose (RP2D) is determined. Each cycle is 21 days. Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum 5-FU Participants with untreated metastatic or unresectable, locally recurrent head and neck squamous cell carcinoma (HNSCC) regardless of programmed cell death ligand 1 (PD-L1) status will receive the following: * magrolimab * pembrolizumab 200 mg on Day 1 of each cycle * 5-fluorouracil (5-FU) 1000 mg/m\^2/day Days 1-4 of each cycle (for up to 6 cycles) * platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin area under the concentration versus time curve (AUC) 5 per investigator choice (for up to 6 cycles)) Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the recommended Phase 2 dose (RP2D) is determined. Each cycle is 21 days. Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum Cisplatin Participants with untreated metastatic or unresectable, locally recurrent head and neck squamous cell carcinoma (HNSCC) regardless of programmed cell death ligand 1 (PD-L1) status will receive the following: * magrolimab * pembrolizumab 200 mg on Day 1 of each cycle * 5-fluorouracil (5-FU) 1000 mg/m\^2/day Days 1-4 of each cycle (for up to 6 cycles) * platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin area under the concentration versus time curve (AUC) 5 per investigator choice (for up to 6 cycles)) Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the recommended Phase 2 dose (RP2D) is determined. Each cycle is 21 days. Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum Carboplatin Participants with untreated metastatic or unresectable, locally recurrent head and neck squamous cell carcinoma (HNSCC) regardless of programmed cell death ligand 1 (PD-L1) status will receive the following: * magrolimab * pembrolizumab 200 mg on Day 1 of each cycle * 5-fluorouracil (5-FU) 1000 mg/m\^2/day Days 1-4 of each cycle (for up to 6 cycles) * platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin area under the concentration versus time curve (AUC) 5 per investigator choice (for up to 6 cycles)) Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the recommended Phase 2 dose (RP2D) is determined. Each cycle is 21 days. Safety Run-in Cohort 2, Magrolimab + Docetaxel Docetaxel Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive the following: * magrolimab * docetaxel 75 mg/m\^2 on Day 1 of each cycle Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the RP2D is determined. Each cycle is 21 days. Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab Pembrolizumab The pre-expansion safety run-in cohort may be conducted at the sponsor's discretion prior to the initiation of Phase 2 Cohort 2. Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) ≥ 1 will receive magrolimab and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days. Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the RP2D is determined. Each cycle is 21 days. Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A) Pembrolizumab Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A) 5-FU Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A) Cisplatin Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A) Carboplatin Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B) Pembrolizumab Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B) 5-FU Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B) Carboplatin Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B) Cisplatin Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C) 5-FU Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, zimberelimab 360 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Zimberelimab therapy will be administered up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C) Cisplatin Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, zimberelimab 360 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Zimberelimab therapy will be administered up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C) Zimberelimab Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, zimberelimab 360 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Zimberelimab therapy will be administered up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C) Carboplatin Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, zimberelimab 360 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Zimberelimab therapy will be administered up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 2, Magrolimab + Pembrolizumab Pembrolizumab Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) ≥ 1 will receive magrolimab at the RP2D determined in the Safety run-in cohort 1 and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 3, Magrolimab + Docetaxel Docetaxel Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive magrolimab at the RP2D determined in the Safety run-in cohort 2 and docetaxel 75 mg/m\^2 on Day 1 of each cycle. Each cycle is 21 days. Magrolimab and docetaxel will be continued until loss of clinical benefit, unacceptable toxicity, or death. Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum Magrolimab Participants with untreated metastatic or unresectable, locally recurrent head and neck squamous cell carcinoma (HNSCC) regardless of programmed cell death ligand 1 (PD-L1) status will receive the following: * magrolimab * pembrolizumab 200 mg on Day 1 of each cycle * 5-fluorouracil (5-FU) 1000 mg/m\^2/day Days 1-4 of each cycle (for up to 6 cycles) * platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin area under the concentration versus time curve (AUC) 5 per investigator choice (for up to 6 cycles)) Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the recommended Phase 2 dose (RP2D) is determined. Each cycle is 21 days. Safety Run-in Cohort 2, Magrolimab + Docetaxel Magrolimab Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive the following: * magrolimab * docetaxel 75 mg/m\^2 on Day 1 of each cycle Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the RP2D is determined. Each cycle is 21 days. Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab Magrolimab The pre-expansion safety run-in cohort may be conducted at the sponsor's discretion prior to the initiation of Phase 2 Cohort 2. Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) ≥ 1 will receive magrolimab and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days. Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the RP2D is determined. Each cycle is 21 days. Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A) Magrolimab Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C) Magrolimab Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, zimberelimab 360 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Zimberelimab therapy will be administered up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 2, Magrolimab + Pembrolizumab Magrolimab Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) ≥ 1 will receive magrolimab at the RP2D determined in the Safety run-in cohort 1 and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. Phase 2 Cohort 3, Magrolimab + Docetaxel Magrolimab Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive magrolimab at the RP2D determined in the Safety run-in cohort 2 and docetaxel 75 mg/m\^2 on Day 1 of each cycle. Each cycle is 21 days. Magrolimab and docetaxel will be continued until loss of clinical benefit, unacceptable toxicity, or death.
- Primary Outcome Measures
Name Time Method Safety Run-in Cohorts: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 First Dose up to 21 days Phase 2 Cohorts 2 and 3: Objective Response Rate (ORR) Up to 9 months ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as determined by investigator assessment.
Phase 2 Cohorts 1: Progression-free Survival (PFS) Up to 5 years PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, as assessed by investigator assessment, or death from any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Safety Run-In and Phase 2 Cohorts: Serum Concentration of Magrolimab Up to end of treatment (approximately 24 months) Safety Run-In and Phase 2 Cohorts: Percentage of Participants who Developed Antidrug Antibodies (ADAs) to Magrolimab Up to end of treatment (approximately 24 months) Phase 2 Cohorts: Progression-free Survival (PFS) Up to 5 years PFS is defined as the time from the date of randomization (Phase 2 Cohorts 1) or date of dose initiation (Phase 2 Cohorts 2 and 3) until the earliest date of documented disease progression as determined by investigator assessment per RECIST, version 1.1, or death from any cause, whichever occurs first.
Phase 2 Cohorts: Change from Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Baseline; up to 24 months The EORTC QLQ-C30 questionnaire is a specific questionnaire for cancer, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).
Phase 2 Cohorts: Overall Survival (OS) Up to 5 years OS is defined as the time from the date of randomization (Phase 2 Cohorts 1) or time from the date of dose initiation (Phase 2 Cohorts 2 and 3) to death from any cause.
Phase 2 Cohorts: Change from Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Baseline; up to 24 months The head \& neck cancer module is a 35-item questionnaire designed for use among a wide range of participants with head \& neck cancer, varying in disease stage and treatment modality. It includes 7 multi-item scales that assess pain (4 items), swallowing (4 items), senses (2 items), speech (3 items), social eating (4 items), social contact (5 items), and sexuality (2 items). There are also 11 single items. Using a 4-point Likert scale, participants indicate the degree to which they have experienced symptoms. For all items and scales, high scores indicate more problems.
Phase 2 Cohorts: Change From Baseline in the 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Baseline; up to 24 months The EQ-5D-5L is a standard measure of health-related quality of life. The tool consists of the EQ-5D-5L descriptive part and the EQ visual analogue scale (VAS). The descriptive part comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each of these 5 dimensions has 5 levels (no problem, slight problems, moderate problems, severe problems, and extreme problems). Results for each of the 5 dimensions are combined into a 5-digit number to describe the participant's health state.
The EQ-VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine." Higher scores of EQ VAS indicate better health.Phase 2 Cohorts: Objective Response Rate (ORR) Up to 9 months ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as determined by investigator assessment.
Phase 2 Cohorts: Duration of Response (DOR) Up to 5 years DOR is defined as the time from first documentation of CR or PR to the earliest date of documented disease progression or death from any cause, whichever occurs first.
Trial Locations
- Locations (87)
UCLA Hematology/Oncology
🇺🇸Los Angeles, California, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Algemeen Ziekenhuis Klina
🇧🇪Brasschaat, Belgium
Hospital de Braga
🇵🇹Braga, Portugal
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Ironwood Cancer and Research Center
🇺🇸Chandler, Arizona, United States
Torrance Memorial Physician Network - Cancer Care Associates
🇺🇸Redondo Beach, California, United States
University Center and Blood Center,LLC.
🇺🇸Athens, Georgia, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Virginia Piper Cancer Center (Alliant Health
🇺🇸Minneapolis, Minnesota, United States
Washington University of Medicine- Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital
🇺🇸New York, New York, United States
Astera Cancer Care
🇺🇸East Brunswick, New Jersey, United States
New York Cancer and Blood Specialists
🇺🇸Port Jefferson Station, New York, United States
Sanford Roger Maris Cancer Center
🇺🇸Fargo, North Dakota, United States
MD Anderson Cancer Center
🇪🇸Madrid, Spain
Blacktown Hospital
🇦🇺Westmead, New South Wales, Australia
Macquarie University
🇦🇺Macquarie Park, New South Wales, Australia
University of the Sunshine Coast
🇦🇺Sippy Downs, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg
🇧🇪Antwerpen, Belgium
Alfred Health
🇦🇺Melbourne, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
UZ Antwerpen
🇧🇪Edegem, Belgium
AZ Sint-Maarten
🇧🇪Mechelen, Belgium
Universitaire Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Institut Bergonie
🇫🇷Bordeaux, France
CHU UCL Namur - Sainte-Elisabeth
🇧🇪Namur, Belgium
Institut Curie
🇫🇷Paris, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Centre Léon Bérard
🇫🇷Lyon, France
Hopital de la Timone
🇫🇷Marseille, France
Hopital Pitie-Salpetriere
🇫🇷Paris, France
Civils de Lyon-Centre Hopitalier Lyon Sud
🇫🇷Pierre-benite, France
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III
🇩🇪Bonn, Germany
Institut Gustave Roussy
🇫🇷Villejuif, France
Charite University Medicine
🇩🇪Berlin, Germany
Hopital Foch
🇫🇷Suresnes, France
Universitatsmedizin Gottingen
🇩🇪GÃttingen, Germany
Kath. Marienkrankenhaus gGmbH
🇩🇪Hamburg, Germany
Universitäres Krebszentrum Leipzig
🇩🇪Leipzig, Germany
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Azienda Ospedaliero - Universitaria Senese
🇮🇹Siena, Italy
ASST degli Spedali Civili di Brescia
🇮🇹Brescia, Italy
Princess Margaret Hospital
🇭🇰Lai Chi Kok, Hong Kong
Ospedale San Luca Luca
🇮🇹Lucca, Italy
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie, Oddzial Onkologii Klinicznej i Immunookologii z Poddoddzialem Dziennym i Izba Przyjec
🇵🇱Poznan, Poland
Wojewodzki Szpital Specjalistyczny w Siedlcach
🇵🇱Siedlce, Poland
Narodowy Instytut Onkologii im. M. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Glowy i Szyi
🇵🇱Warsaw, Poland
Centro Hospitalar do Algarve
🇵🇹Faro, Portugal
Centro Hospitalar Universitario do Porto
🇵🇹Porto, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil,E.P.E.
🇵🇹Porto, Portugal
Hospital De La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton
🇬🇧London, United Kingdom
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom
City of Hope
🇺🇸Duarte, California, United States
Stanford Cancer Institute
🇺🇸Palo Alto, California, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
OU Health Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
St. Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Cairns Hospital
🇦🇺Cairns, Queensland, Australia
Centre Hospitalizer De L'Ardenne
🇧🇪Libramont-Chevigny, Belgium
Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est
🇫🇷Nice, France
Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar
🇩🇪Munich, Germany
Azienda Ospedaliero - Universitaria di Bologna - IRCCS
🇮🇹Bologna, Italy
Azienda Ospedaliero-Universitaria di Modena - Policlinico
🇮🇹Modena, Italy
Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
Fondazione IRCCS Istituto Nazionale Tumori Milano
🇮🇹Milan, Italy
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Panstwowy Instytut Badawczy, Oddzial x Gliwicach
🇵🇱Gliwice, Poland
Hospital CUF Descobertas
🇵🇹Lisboa, Portugal
Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA
🇵🇹Matosinhos, Portugal
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario de Jaen
🇪🇸Jaen, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga
🇪🇸Malaga, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
Providence Medical Foundation
🇺🇸Santa Rosa, California, United States
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States