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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

73 sites in 15 countries.

About this study

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

Conditions

Uterine Cervical Neoplasms, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck, Gallbladder Neoplasms, Cholangiocarcinoma, Esophageal Neoplasms

Being tested

Pembrolizumab/Vibostolimab Co-Formulation, Pembrolizumab, Lenvatinib, 5-Fluorouracil, Cisplatin

Keywords

Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

Medical subject headings

Uterine Cervical Neoplasms, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck, Gallbladder Neoplasms, Cholangiocarcinoma, Esophageal Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Pembrolizumab/Vibostolimab Co-FormulationBiological

  Also called MK-7684A

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

• PembrolizumabBiological

  Also called MK-3475, KEYTRUDA®

  Pembrolizumab 200 mg administered via IV infusion Q3W.

• LenvatinibDrug

  Also called Lenvima, E7080, MK-7902

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

• 5-FluorouracilDrug

  Also called 5-FU, Fluracil

  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

• CisplatinDrug

  Also called Platinol, cis Platinum

  Cisplatin administered via IV infusion

• PaclitaxelDrug

  Also called Taxol, Abraxane, Anzatax

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

• GemcitabineDrug

  Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity

• CarboplatinDrug

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

• DocetaxelDrug

  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

• BevacizumabDrug

  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

• CapecitabineDrug

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

• OxaliplatinDrug

  Oxaliplatin administered via IV infusion Q3W up to 35 cycles

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) in Cohort A1

   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 was presented. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The ORR was calculated using the Miettinen \& Nurminen method stratified by prior bevacizumab use interactive voice response system (IVRS). ORR as assessed by BICR in Cohort A1 is presented.

   Measured: Up to approximately 24 months

2. Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR in Cohort A1

   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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method. PFS as assessed by BICR in Cohort A1 is presented.

   Measured: Up to approximately 24 months

3. ORR Per RECIST 1.1 as Assessed by Investigator in Participants With Selected Solid Tumors

   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 in selected solid tumors as assessed by investigator based on RECIST 1.1 is presented. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, Cohort A1 and Cohort I were excluded in the analysis. ORR as assessed by Investigator based on RECIST 1.1 is presented.

   Measured: Up to approximately 24 months

4. Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator at 9 Months

   PFS is defined as the time from the first dose of study intervention 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-9 is defined as the proportion of participants free of documented progression per RECIST 1.1 by investigator or death due to any cause at 9 months from the first dose of study intervention. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method. PFS at 9 months as assessed by Investigator based on RECIST 1.1 in Cohort I is presented.

   Measured: 9 months

5. PFS Per RECIST 1.1 as Assessed by Investigator at 12 Months

   PFS is defined as the time from the first dose of study intervention 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-12 is defined as the proportion of participants free of documented progression per RECIST 1.1 by investigator or death due to any cause at 12 months from the first dose of study intervention. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method. PFS at 12 months as assessed by Investigator based on RECIST 1.1 in Cohort I is presented.

   Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted16 Aug 2021
2. Study start16 Sep 2021
3. Primary completion5 Aug 2025
4. Study completion5 Aug 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
• More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.