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

Conditions

• Cholangiocarcinoma
• Endometrial Neoplasms
• Esophageal Neoplasms
• Gallbladder Neoplasms
• Hepatocellular Carcinoma
• Ovarian Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• Stomach Neoplasms
• Triple Negative Breast Neoplasms
• Urinary Bladder Neoplasms
• Uterine Cervical Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab/Vibostolimab Co-Formulation — BIOLOGICAL
  Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
• Pembrolizumab — BIOLOGICAL
  Pembrolizumab 200 mg administered via IV infusion Q3W.
• Lenvatinib — DRUG
  Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD
• 5-Fluorouracil — DRUG
  5-FU 800 mg/m\^2/day administered via continuous IV infusion on each of days 1 to 5 Q3W for up to 35 cycles
• Cisplatin — DRUG
  Cisplatin administered via IV infusion
• Paclitaxel — DRUG
  Paclitaxel administered via IV infusion at investigator's choice of dose
• Gemcitabine — DRUG
  Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity
• Carboplatin — DRUG
  Carboplatin administered via IV infusion at investigator's choice of dose and frequency
• Docetaxel — DRUG
  For participants who cannot receive paclitaxel due to hypersensitivity or adverse event (AE), docetaxel administered via IV infusion Q3W, Day 1 of each cycle for up to 5 cycles
• Bevacizumab — DRUG
  Bevacizumab (or biosimilars such as MVASI®, Zirabev®, Aybintio®, ALYMSYS®, Abevmy®, Onbevezy®, Vegzelma®) administered via IV infusion Q3W; Day 1 of each 3-week cycle for up to 15 cycles
• Capecitabine — DRUG
  Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles
• Oxaliplatin — DRUG
  Oxaliplatin administered via IV infusion Q3W up to 35 cycles

Study Details

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.

Key Dates

First listed

Aug 16, 2021

Start date

Sep 16, 2021

Status verified

Aug 2025

Primary completion

Aug 5, 2025

Completion

Aug 5, 2025

Study Design

Enrollment

613 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: Pembrolizumab
  Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.
• Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort)
  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.
• Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort)
  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.
• Experimental: Pembrolizumab/Vibostolimab + 5-Fluorouracil + 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.
• Experimental: Pembrolizumab/Vibostolimab Co-Formulation + 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.
• Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/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
• Experimental: Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/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.
• Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/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 Measure

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 2 years ]

Locations (14)

Find similar trials in Anchorage, AK

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