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

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ClinicalTrials.gov Identifier: NCT05007106
Recruitment Status : Recruiting
First Posted : August 16, 2021
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Endometrial Neoplasms Squamous Cell Carcinoma of Head and Neck Gallbladder Neoplasms Cholangiocarcinoma Esophageal Neoplasms Triple Negative Breast Neoplasms Hepatocellular Carcinoma Urinary Bladder Neoplasms Ovarian Neoplasms Stomach Neoplasms Biological: Pembrolizumab/Vibostolimab Co-Formulation Biological: Pembrolizumab Drug: Lenvatinib Drug: 5-Fluorouracil Drug: Cisplatin Drug: Paclitaxel Drug: Gemcitabine Drug: Carboplatin Drug: Docetaxel Drug: Bevacizumab Drug: Capecitabine Drug: Oxaliplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants with locally recurrent unresectable or metastatic cervical cancer whose tumors express programmed cell death 1 ligand 1 (PD-LI) and have a combined positive score (CPS) ≥1 will be randomly assigned to treatment with either pembrolizumab/vibostolimab co-formulation or pembrolizumab only. The other study intervention arms will be assigned to participants depending on the selected cancer type.
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 16, 2021
Estimated Primary Completion Date : February 22, 2027
Estimated Study Completion Date : February 22, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Other Name: MK-7684A
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.
 Biological: Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
Other Names:
  • MK-3475
  • KEYTRUDA®
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) until meeting discontinuation criteria.
 Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Other Name: MK-7684A

Drug: Lenvatinib
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
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 until meeting discontinuation criteria.
 Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Other Name: MK-7684A

Drug: Lenvatinib
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
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.
 Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Other Name: MK-7684A

Drug: 5-Fluorouracil
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

Drug: Cisplatin
Cisplatin administered via IV infusion
Other Names:
  • Platinol
  • cis Platinum
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.
 Biological: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Other Name: MK-7684A

Drug: Paclitaxel
Paclitaxel administered via IV infusion at investigator's choice of dose
Other Names:
  • Taxol
  • Abraxane
  • Anzatax
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.
 Drug: Cisplatin
Cisplatin administered via IV infusion
Other Names:
  • Platinol
  • cis Platinum

Drug: Gemcitabine
Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity
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 background therapy.
 Drug: Paclitaxel
Paclitaxel administered via IV infusion at investigator's choice of dose
Other Names:
  • Taxol
  • Abraxane
  • Anzatax

Drug: Carboplatin
Carboplatin administered via IV infusion at investigator's choice of dose and frequency

Drug: Docetaxel
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

Drug: Bevacizumab
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
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.
 Drug: Capecitabine
Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles

Drug: Oxaliplatin
Oxaliplatin administered via IV infusion Q3W up to 35 cycles


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05007106


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05007106    
Other Study ID Numbers: 7684A-005
MK-7684A-005 ( Other Identifier: Merck )
jRCT2031210335 ( Registry Identifier: jRCT )
KEYVIBE-005 ( Other Identifier: Merck )
2023-505284-36 ( Other Identifier: EU CT )
2021-001009-56 ( EudraCT Number )
First Posted: August 16, 2021    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme LLC:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Cholangiocarcinoma
Breast Neoplasms
Ovarian Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Squamous Cell Carcinoma of Head and Neck
Uterine Cervical Neoplasms
Urinary Bladder Neoplasms
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Gallbladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Carcinoma, Squamous Cell
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female