MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
- Conditions
- Endometrial NeoplasmsUterine Cervical NeoplasmsSquamous Cell Carcinoma of Head and NeckUrinary Bladder NeoplasmsCholangiocarcinomaEsophageal NeoplasmsOvarian NeoplasmsTriple Negative Breast NeoplasmsHepatocellular CarcinomaGallbladder Neoplasms
- Interventions
- Biological: Pembrolizumab/Vibostolimab Co-Formulation
- Registration Number
- NCT05007106
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 613
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One of the following histologically or cytologically confirmed, advanced (unresectable or metastatic) solid tumors:
- Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
- Endometrial cancer
- Head and neck squamous cell carcinoma (HNSCC)
- Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma)
- Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).
- Triple-negative breast cancer (TNBC)
- Hepatocellular carcinoma (HCC)
- Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
- Ovarian cancer
- Gastric cancer
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Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.
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Adequately controlled blood pressure (BP) with or without antihypertensive medications.
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Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
-
Male participants must agree to follow contraceptive guidance.
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Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance.
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Adequate organ function.
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
- Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent.
- Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- Active infection requiring systemic therapy.
- Concurrent active hepatitis B and hepatitis C virus infection.
- History of allogenic tissue/solid organ transplant.
- Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm).
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab/Vibostolimab Co-Formulation Pembrolizumab/Vibostolimab Co-Formulation Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion every 3 weeks (Q3W) up to 35 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy. Pembrolizumab/Vibostolimab Co-Formulation Pembrolizumab Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion every 3 weeks (Q3W) up to 35 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy. Pembrolizumab Pembrolizumab Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles. Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort) Pembrolizumab/Vibostolimab Co-Formulation Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 20 mg once daily (qd) up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib. Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort) Pembrolizumab Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 20 mg once daily (qd) up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib. Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort) Lenvatinib Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 20 mg once daily (qd) up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib. Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort) Pembrolizumab/Vibostolimab Co-Formulation Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 12 mg (body weight \[BW\] ≥60 kg) or lenvatinib 8 mg (BW \<60 kg) qd up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib. Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort) Pembrolizumab Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 12 mg (body weight \[BW\] ≥60 kg) or lenvatinib 8 mg (BW \<60 kg) qd up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib. Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort) Lenvatinib Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 12 mg (body weight \[BW\] ≥60 kg) or lenvatinib 8 mg (BW \<60 kg) qd up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib. Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin Pembrolizumab/Vibostolimab Co-Formulation Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W, plus 5-fluorouracil (5-FU), plus Cisplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with 5-Fluorouracil + Cisplatin. Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin Pembrolizumab Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W, plus 5-fluorouracil (5-FU), plus Cisplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with 5-Fluorouracil + Cisplatin. Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin 5-Fluorouracil Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W, plus 5-fluorouracil (5-FU), plus Cisplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with 5-Fluorouracil + Cisplatin. Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin Cisplatin Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W, plus 5-fluorouracil (5-FU), plus Cisplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with 5-Fluorouracil + Cisplatin. Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel Pembrolizumab/Vibostolimab Co-Formulation Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus paclitaxel as background therapy until meeting discontinuation criteria. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Paclitaxel. Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel Pembrolizumab Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus paclitaxel as background therapy until meeting discontinuation criteria. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Paclitaxel. Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel Paclitaxel Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus paclitaxel as background therapy until meeting discontinuation criteria. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Paclitaxel. Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin Pembrolizumab Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus gemcitabine (until disease progression or unacceptable toxicity) and cisplatin (up to 8 cycles) as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Gemcitabine/Cisplatin Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin Cisplatin Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus gemcitabine (until disease progression or unacceptable toxicity) and cisplatin (up to 8 cycles) as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Gemcitabine/Cisplatin Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin Gemcitabine Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus gemcitabine (until disease progression or unacceptable toxicity) and cisplatin (up to 8 cycles) as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Gemcitabine/Cisplatin Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab Pembrolizumab Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus carboplatin, paclitaxel, and bevacizumab as local standard of care (SOC) background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Carboplatin/Paclitaxel/Bevacizumab. Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab Paclitaxel Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus carboplatin, paclitaxel, and bevacizumab as local standard of care (SOC) background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Carboplatin/Paclitaxel/Bevacizumab. Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab Carboplatin Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus carboplatin, paclitaxel, and bevacizumab as local standard of care (SOC) background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Carboplatin/Paclitaxel/Bevacizumab. Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab Docetaxel Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus carboplatin, paclitaxel, and bevacizumab as local standard of care (SOC) background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Carboplatin/Paclitaxel/Bevacizumab. Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab Bevacizumab Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus carboplatin, paclitaxel, and bevacizumab as local standard of care (SOC) background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Carboplatin/Paclitaxel/Bevacizumab. Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin Capecitabine Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus capecitabine and oxaliplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Capecitabine/Oxaliplatin. Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin Pembrolizumab Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus capecitabine and oxaliplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Capecitabine/Oxaliplatin. Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin Oxaliplatin Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus capecitabine and oxaliplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Capecitabine/Oxaliplatin.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) Up to approximately 2 years ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR Up to approximately 2 years PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
PFS per RECIST 1.1 as Assessed by Investigator at 9 months 9 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
ORR per RECIST 1.1 as Assessed by Investigator in Participants with Selected Solid Tumors Up to approximately 2 years ORR is defined as the percentage of participants who have a CR (Disappearance of all target lesions) or a PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by investigator based on RECIST 1.1 will be presented.
PFS per RECIST 1.1 as Assessed by Investigator at 12 months 12 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR Up to approximately 2 years For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by BICR will be presented.
DOR per RECIST 1.1 as Assessed by Investigator Up to approximately 2 years For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by investigator will be presented.
ORR per RECIST 1.1 as Assessed by Investigator Up to approximately 2 years ORR is defined as the percentage of participants who have a CR (Disappearance of all target lesions) or a PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by investigator based on RECIST 1.1 will be presented.
Number of Participants Who Discontinued Study Intervention Due to an AE Up to approximately 2 years An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5) Baseline and up to approximately 2 years The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
Number of Participants Who Experienced One or More Adverse Events (AEs) Up to approximately 2 years An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Overall Survival (OS) Up to approximately 5.5 years OS is defined as the time from randomization to death due to any cause.
PFS per RECIST 1.1 as Assessed by Investigator Up to approximately 2 years PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator will be presented.
PFS per RECIST 1.1 as Assessed by Investigator in Participants with Cervical Cancer Up to approximately 2 years PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator will be presented.
Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30) Baseline and up to approximately 2 years The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Trial Locations
- Locations (73)
Memorial Sloan Kettering - Bergen ( Site 1025)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering - Monmouth ( Site 1022)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering - Basking Ridge ( Site 1023)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering - Westchester ( Site 1020)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering- Commack ( Site 1021)
🇺🇸Commack, New York, United States
Institut Curie ( Site 1152)
🇫🇷Paris, France
City of Hope Comprehensive Cancer Center ( Site 1001)
🇺🇸Duarte, California, United States
Hadassah Medical Center-Oncology ( Site 1142)
🇮🇱Jerusalem, Israel
Alaska Womens Cancer Care ( Site 1016)
🇺🇸Anchorage, Alaska, United States
Gustave Roussy-medicine departement ( Site 1153)
🇫🇷Villejuif, Paris, France
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101
🇵🇱Warszawa, Mazowieckie, Poland
Ospedale San Raffaele-Oncologia Medica ( Site 1135)
🇮🇹Milano, Lombardia, Italy
Sheba Medical Center-ONCOLOGY ( Site 1144)
🇮🇱Ramat Gan, Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)
🇮🇹Napoli, Italy
Asan Medical Center ( Site 1313)
🇰🇷Seoul, Korea, Republic of
Centre Georges François Leclerc ( Site 1155)
🇫🇷Dijon, Cote-d Or, France
Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
🇺🇸Sioux Falls, South Dakota, United States
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)
🇩🇪Berlin, Germany
Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)
🇩🇪Heidelberg, Baden-Wurttemberg, Germany
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)
🇰🇷Seoul, Korea, Republic of
National Cancer Center Hospital East ( Site 1321)
🇯🇵Kashiwa, Chiba, Japan
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)
🇵🇱Gdansk, Pomorskie, Poland
Seoul National University Hospital-Internal Medicine ( Site 1312)
🇰🇷Seoul, Korea, Republic of
Institut Regional du Cancer Montpellier ( Site 1157)
🇫🇷Montpellier, Herault, France
Rambam Health Care Campus-Oncology ( Site 1141)
🇮🇱Haifa, Israel
Istanbul Universitesi Cerrahpasa ( Site 1203)
🇹🇷Istanbul- Fatih, Istanbul, Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)
🇹🇷Istanbul, Turkey
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1121)
🇳🇱Amsterdam, Noord-Holland, Netherlands
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)
🇪🇸Hospitalet, Barcelona, Spain
Acibadem Universitesi Atakent Hastanesi ( Site 1208)
🇹🇷Istanbul, Turkey
Osaka International Cancer Institute ( Site 1323)
🇯🇵Osaka, Japan
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hacettepe Universitesi-oncology hospital ( Site 1209)
🇹🇷Ankara, Turkey
Ankara City Hospital-Medical Oncology ( Site 1202)
🇹🇷Ankara, Turkey
James Lind Centro de Investigacion del Cancer ( Site 1404)
🇨🇱Temuco, Araucania, Chile
Fundación Cardiovascular de Colombia ( Site 1423)
🇨🇴Piedecuesta, Santander, Colombia
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1422)
🇨🇴Medellin, Antioquia, Colombia
Chang Gung Medical Foundation-Linkou Branch ( Site 1304)
🇨🇳Taoyuan, Taiwan
Oncologos del Occidente ( Site 1424)
🇨🇴Pereira, Risaralda, Colombia
National Taiwan University Hospital-Oncology ( Site 1301)
🇨🇳Taipei, Taiwan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136)
🇮🇹Roma, Lazio, Italy
NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)
🇨🇳Tainan, Taiwan
Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)
🇫🇷Avignon, Vaucluse, France
Mackay Memorial Hospital ( Site 1305)
🇨🇳Taipei, Taiwan
Karmanos Cancer Institute ( Site 1007)
🇺🇸Detroit, Michigan, United States
Houston Methodist Hospital ( Site 1017)
🇺🇸Houston, Texas, United States
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
🇮🇹Milano, Italy
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
Memorial Sloan Kettering - Nassau ( Site 1026)
🇺🇸Uniondale, New York, United States
Aichi Cancer Center Hospital ( Site 1324)
🇯🇵Nagoya, Aichi, Japan
Clinica Universidad de Navarra-Medical Oncology ( Site 1118)
🇪🇸Madrid, Spain
University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
🇺🇸Orange, California, United States
Memorial Sloan Kettering Cancer Center ( Site 1002)
🇺🇸New York, New York, United States
Princess Margaret Cancer Centre ( Site 1056)
🇨🇦Toronto, Ontario, Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)
🇨🇦Kingston, Ontario, Canada
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024)
🇺🇸Tulsa, Oklahoma, United States
Oncovida ( Site 1405)
🇨🇱Santiago, Region M. De Santiago, Chile
FALP-UIDO ( Site 1401)
🇨🇱Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 1402)
🇨🇱Santiago, Region M. De Santiago, Chile
Clinica de la Costa S.A.S. ( Site 1421)
🇨🇴Barranquilla, Atlantico, Colombia
Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)
🇨🇴Bogotá, Cundinamarca, Colombia
CENTRE LEON BERARD-Medical oncology ( Site 1151)
🇫🇷Lyon, Rhone-Alpes, France
Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne
🇩🇪Tübingen, Baden-Wurttemberg, Germany
Klinikum der Universität München Großhadern ( Site 1176)
🇩🇪München, Bayern, Germany
Sourasky Medical Center-Oncology ( Site 1143)
🇮🇱Tel Aviv, Israel
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1138)
🇮🇹Rozzano, Milano, Italy
National Cancer Center Hospital ( Site 1322)
🇯🇵Tokyo, Japan
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)
🇵🇱Koszalin, Zachodniopomorskie, Poland
Erasmus Medisch Centrum-Medical Oncology ( Site 1122)
🇳🇱Rotterdam, Zuid-Holland, Netherlands
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)
🇪🇸Sevilla, Spain
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)
🇹🇷Adana, Turkey
Trakya University-Medical Oncology ( Site 1207)
🇹🇷Edirne, Turkey