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ONCOVIDA | Santiago, Chile

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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling
Phase 2

Conditions

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

Treatments

Drug: Docetaxel
Drug: Gemcitabine
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Biological: Pembrolizumab
Drug: Capecitabine
Drug: Carboplatin
Drug: Paclitaxel
Drug: 5-Fluorouracil
Drug: Bevacizumab
Drug: Oxaliplatin
Drug: Lenvatinib
Drug: Cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05007106
MK-7684A-005 (Other Identifier)
KEYVIBE-005 (Other Identifier)
2021-001009-56 (EudraCT Number)
2023-505284-36 (Other Identifier)
7684A-005
jRCT2031210335 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

610 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

610 participants in 9 patient groups

Pembrolizumab/Vibostolimab Co-Formulation
Experimental group
Description:
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.
Treatment:
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab
Experimental group
Description:
Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.
Treatment:
Biological: Pembrolizumab
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort)
Experimental group
Description:
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.
Treatment:
Drug: Lenvatinib
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort)
Experimental group
Description:
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
Treatment:
Drug: Lenvatinib
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin
Experimental group
Description:
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.
Treatment:
Drug: Cisplatin
Drug: 5-Fluorouracil
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel
Experimental group
Description:
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.
Treatment:
Drug: Paclitaxel
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin
Experimental group
Description:
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.
Treatment:
Drug: Cisplatin
Drug: Gemcitabine
Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab
Experimental group
Description:
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.
Treatment:
Drug: Bevacizumab
Drug: Paclitaxel
Drug: Carboplatin
Drug: Docetaxel
Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin
Experimental group
Description:
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.
Treatment:
Drug: Capecitabine
Drug: Oxaliplatin

Trial contacts and locations

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Toll Free Number

Data sourced from clinicaltrials.gov

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