Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT02720068
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • Favezelimab — BIOLOGICAL
    IV infusion
  • Pembrolizumab — BIOLOGICAL
    IV infusion
  • Oxaliplatin — DRUG
    IV infusion
  • Irinotecan — DRUG
    IV infusion
  • Leucovorin (Calcium Folinate) — DRUG
    IV infusion
  • Fluorouracil [5-FU] — DRUG
    IV infusion
  • Favezelimab/Pembrolizumab — BIOLOGICAL
    IV infusion
  • Lenvatinib — DRUG
    Oral

Study Details

This is a safety and pharmacokinetics study of favezelimab as monotherapy and in combination with pembrolizumab AND favezelimab/pembrolizumab as monotherapy in adults with metastatic solid tumors for which there is no available therapy which may convey clinical benefit. Part A of this study is a dose escalation design in which participants receive favezelimab as monotherapy or favezelimab in combination with pembrolizumab. Part B is a dose confirmation design to estimate the recommended Phase 2 dose (RP2D), as determined by dose-limiting toxicity, for favezelimab in combination with pembrolizumab or pembrolizumab and lenvatinib in participants with advanced solid tumors. Part B will also assess the efficacy of favezelimab as monotherapy; favezelimab in combination with pembrolizumab with and without chemotherapy; favezelimab in combination with pembrolizumab and lenvatinib; and favezelimab/pembrolizumab as monotherapy in expansion cohorts. Participants who have completed the initial course of treatment and have investigator-determined progressive disease may be eligible for a second course of an additional 17 cycles of study treatment.

Key Dates

Start date
May 2, 2016
Status verified
May 2025
Primary completion
Mar 15, 2024
Completion
Mar 15, 2024

Study Design

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

Arms

  • Experimental: Part A: Favezelimab 7 mg Monotherapy
    Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
  • Experimental: Part A: Favezelimab 21 mg Monotherapy
    Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
  • Experimental: Part A: Favezelimab 70 mg Monotherapy
    Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
  • Experimental: Part A: Favezelimab 210 mg Monotherapy
    Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
  • Experimental: Part A: Favezelimab 700 mg Monotherapy
    Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.
  • Experimental: Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
    Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
  • Experimental: Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
    Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
  • Experimental: Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
    Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
  • Experimental: Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
    Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
  • Experimental: Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
    Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
  • Experimental: Part B: Favezelimab 800 mg Monotherapy (Arm 1)
    Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.
  • Experimental: Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)
    Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
  • Experimental: Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)
    Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
  • Experimental: Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)
    Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
  • Experimental: Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)
    Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]).
  • Experimental: Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)
    Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W).
  • Experimental: Part B: MK-4280A (Arm 5)
    Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
  • Experimental: Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)
    Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.

Primary Outcome Measure

Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 21 days (Cycle 1) ]

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