MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

Phase 2

Active, not recruiting

• Conditions: Endometrial Neoplasms; Uterine Cervical Neoplasms; Squamous Cell Carcinoma of Head and Neck; Urinary Bladder Neoplasms; Cholangiocarcinoma; Esophageal Neoplasms; Ovarian Neoplasms; Triple Negative Breast Neoplasms; Hepatocellular Carcinoma; Gallbladder Neoplasms
• Interventions: Biological: Pembrolizumab/Vibostolimab Co-Formulation; Biological: Pembrolizumab; Drug: Capecitabine; Drug: Lenvatinib; Drug: 5-Fluorouracil; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Carboplatin; Drug: Oxaliplatin; Drug: Cisplatin; Drug: Docetaxel; Drug: Bevacizumab

• 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

Study Timeline

• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-16
• Study Start: 2021-09-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 613

Inclusion Criteria

• 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

• Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.

• Adequately controlled blood pressure (BP) with or without antihypertensive medications.

• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

• Male participants must agree to follow contraceptive guidance.

• 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.

• Adequate organ function.

Exclusion Criteria

• 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)

Alaska Womens Cancer Care ( Site 1016); 🇺🇸 Anchorage, Alaska, United States

City of Hope Comprehensive Cancer Center ( Site 1001); 🇺🇸 Duarte, California, United States

University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente; 🇺🇸 Orange, California, United States

Karmanos Cancer Institute ( Site 1007); 🇺🇸 Detroit, Michigan, United States

Memorial Sloan Kettering - Basking Ridge ( Site 1023); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering - Monmouth ( Site 1022); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering - Bergen ( Site 1025); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering- Commack ( Site 1021); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering - Westchester ( Site 1020); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 1002); 🇺🇸 New York, New York, United States

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