Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001)

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03179436
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quavonlimab — BIOLOGICAL
    Quavonlimab is administered intravenously (IV) during the Dose Escalation Phase and Dose Confirmation Phase at either DL1 or DL2, and is administered IV during the Efficacy Expansion Phase at DL2.
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab is administered IV at PDL1 on Day 1 of each cycle starting Cycle 2 for the Dose Escalation Phase or starting Cycle 1 of the Dose Confirmation Phase. Pembrolizumab is administered IV at PDL2 on Day 1 of each cycle for the Efficacy Expansion Phase (Arm G).
  • Pembrolizumab/Quavonlimab — DRUG
    Pembrolizumab/Quavonlimab is a coformulated product composed of quavonlimab at DL1 in combination with pembrolizumab at dose level 2 (PDL2).

Study Details

This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumors.

Key Dates

Start date
Jul 2, 2017
Status verified
Mar 2025
Primary completion
Apr 8, 2024
Completion
Apr 8, 2024

Study Design

Enrollment
415 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Escalation: Dose Level (DL) 1 Quavonlimab + Pembro: Cohort 1
    On Cycle 1, Day 1 of the Dose Escalation Phase, advanced solid tumor participants receive a single monotherapy dose lead-in with quavonlimab at dose level 1 (DL1). On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL1 in combination with pembrolizumab (pembro) at pembrolizumab dose level 1 (PDL1) according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.
  • Experimental: Escalation: DL 2 Quavonlimab + Pembro: Cohort 2
    On Cycle 1, Day 1 of the Dose Escalation Phase, participants with advanced solid tumors except NSCLC receive a single monotherapy dose lead-in with quavonlimab at DL2. On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL2 in combination with pembrolizumab at PDL1 according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.
  • Experimental: Escalation: DL 3 Quavonlimab + Pembro: Cohort 3
    On Cycle 1, Day 1 of the Dose Escalation Phase, participants with advanced solid tumors except NSCLC receive a single monotherapy dose lead-in with quavonlimab at DL3. On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL3 in combination with pembrolizumab at PDL1 according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.
  • Experimental: Confirmation: DL 1 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm A
    On Cycle 1, Day 1 of the Dose Confirmation Phase and during all subsequent cycles, participants with NSCLC receive quavonlimab at DL1 in combination with pembrolizumab at PDL1, both according to Schedule 1. Participants will be treated for up to 35 cycles total on study.
  • Experimental: Confirmation: DL 1 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm B
    On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with NSCLC receive quavonlimab at DL1 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and quavonlimab at DL1 according to Schedule 2. Participants will be treated for up to 35 cycles total on study.
  • Experimental: Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm C
    On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with NSCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and at DL2 quavonlimab according to Schedule 2. Participants will be treated for up to 35 cycles total on study.
  • Experimental: Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (SCLC): Arm D
    On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with SCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and quavonlimab at DL2 according to Schedule 2. Participants will be treated for up to 35 cycles total on study.
  • Experimental: Confirmation: DL 2 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm E
    On Cycle 1, Day 1 of the Dose Confirmation Phase and during all subsequent cycles, participants with NSCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1 according to Schedule 1. Participants will be treated for up to 35 cycles total on study.
  • Experimental: Expansion: DL1 Quavonlimab Schedule 2+PDL2 Pembro Schedule 2: Arm F
    On Cycle 1, Day 1 of the Efficacy Expansion Phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma receive quavonlimab at DL1 in combination with pembrolizumab at pembrolizumab dose level 2 (PDL2). Both quavonlimab and pembrolizumab will be administered according to Schedule 2 for up to 24 months on study.
  • Experimental: Expansion: DL1 Quavonlimab Schedule 2 Monotherapy: Arm G
    On Cycle 1, Day 1 of the Efficacy Expansion Phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma receive quavonlimab at DL1 according to Schedule 2 for up to 24 months on study. Participants who demonstrate radiographically confirmed progressive disease in Arm G will be eligible to receive combination therapy with pembrolizumab (crossover).
  • Experimental: Coformulation: Pembrolizumab/Quavonlimab Schedule 2: Arm I
    On Cycle 1, Day 1 of the Coformulation Phase and during all subsequent cycles, participants with advanced/metastatic solid tumors receive pembrolizumab/quavonlimab according to Schedule 2 for up to 24 months on study.
  • Experimental: Coformulation Phase in China: Pembrolizumab/Quavonlimab Schedule 2: Arm K
    On Cycle 1, Day 1 of the Coformulation Phase and during all subsequent cycles, participants in mainland China with advanced solid tumors receive pembrolizumab/quavonlimab according to Schedule 2 for up to 24 months on study.

Primary Outcome Measure

Percentage of Participants With ≥1 Dose Limiting Toxicity (DLT) [ Time Frame: Up to 6 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer Center ( Site 0013)GilbertArizona85234-
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)HackensackNew Jersey07601-
Tennessee Oncology Nashville ( Site 0004)NashvilleTennessee37203-
South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001)San AntonioTexas78229-
Inova Schar Cancer Institute ( Site 1001)FairfaxVirginia22031-4867-

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By research site
Banner MD Anderson Cancer Center· Gilbert, AZJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJTennessee Oncology Nashville· Nashville, TNSouth Texas Accelerated Research Therapeutics, LLC (START)· San Antonio, TXInova Schar Cancer Institute· Fairfax, VA

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