Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03233139
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Malignancies

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Patients will be administered cemiplimab as per protocol. For Cohort A Only, patients with confirmed progressive disease may opt to receive up to 4 cycles of platinum doublet chemotherapy in addition to cemiplimab per investigator's judgement.
  • Ipilimumab — DRUG
    To be administered per protocol
  • Platinum-doublet chemotherapy — DRUG
    To be administered per protocol
  • Gemcitabine — DRUG
    To be administered per protocol
  • Pemetrexed — DRUG
    To be administered per protocol
  • Paclitaxel — DRUG
    To be administered per protocol
  • Fianlimab — DRUG
    To be administered per protocol

Study Details

Part 2 Cohorts A and C This study is being conducted to test the safety and pharmacokinetics of cemiplimab in patients with lung cancer. The study is also being conducted to test if cemiplimab, alone or in combination, can reduce the size of your tumor by helping the immune system destroy the tumor. Part 2 Cohorts D and E This study is being conducted to test the safety and pharmacokinetics of fianlimab and cemiplimab in patients with lung cancer. The study is also being conducted to test if fianlimab and cemiplimab, with or without chemotherapy, can reduce the size of your tumor by helping the immune system destroy the tumor.

Key Dates

Start date
Jun 21, 2017
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
146 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab
    Part 1
  • Experimental: Cohort A
    Part 2
  • Experimental: Cohort B
    Part 2
  • Experimental: Cohort C
    Part 2
  • Experimental: Cohort D
    Part 2
  • Experimental: Cohort E
    Part 2

Primary Outcome Measure

Incidence and severity of treatment-emergent adverse events (TEAEs) in patients treated with cemiplimab as monotherapy [ Time Frame: Up to 136 weeks ]

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