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Completed

NCT Number: NCT05007106

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

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.

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Key information

Conditions

Uterine Cervical Neoplasms Adenocarcinoma Adnexal Diseases Biliary Tract Diseases Biliary Tract Neoplasms Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Hepatocellular Carcinoma, Squamous Cell Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gallbladder Diseases Gallbladder Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Parkinson Disease 4, Autosomal Dominant Lewy Body Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Triple Negative Breast Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051), Kingston, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pembrolizumab/Vibostolimab Co-Formulation

Biological

Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W

Other names: MK-7684A

Pembrolizumab

Biological

Pembrolizumab 200 mg administered via IV infusion Q3W.

Other names: MK-3475, KEYTRUDA®

Lenvatinib

Drug

Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD

Other names: Lenvima, E7080, MK-7902

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

Other names: 5-FU, Fluracil

Cisplatin

Drug

Cisplatin administered via IV infusion

Other names: Platinol, cis Platinum

paclitaxel

Drug

Paclitaxel administered via IV infusion at investigator's choice of dose

Other names: Taxol, Abraxane, Anzatax

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

Primary outcomes

  1. 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

    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.

  2. Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR

    Time frame: 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.

  3. ORR per RECIST 1.1 as Assessed by Investigator in Participants with Selected Solid Tumors

    Time frame: 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.

  4. PFS per RECIST 1.1 as Assessed by Investigator at 9 months

    Time frame: 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.

  5. PFS per RECIST 1.1 as Assessed by Investigator at 12 months

    Time frame: 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 outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 5.5 years

    OS is defined as the time from randomization to death due to any cause.

  2. PFS per RECIST 1.1 as Assessed by Investigator

    Time frame: 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.

  3. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

    Time frame: 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.

  4. DOR per RECIST 1.1 as Assessed by Investigator

    Time frame: 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.

  5. ORR per RECIST 1.1 as Assessed by Investigator

    Time frame: 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.

  6. PFS per RECIST 1.1 as Assessed by Investigator in Participants with Cervical Cancer

    Time frame: 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.

  7. 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)

    Time frame: 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.

  8. Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5)

    Time frame: 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.

  9. Number of Participants Who Experienced One or More Adverse Events (AEs)

    Time frame: 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.

  10. Number of Participants Who Discontinued Study Intervention Due to an AE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2021
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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