INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)

Sponsor
Incyte Corporation
Study ID
NCT03920839
Phase
PHASE1
Status
Withdrawn

Conditions

  • Advanced and/or Metastatic Solid Tumors
  • Advanced/Metastatic Unresectable Malignant Pleural Mesothelioma
  • Stage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Retifanlimab — DRUG
    INCMGA00012 administered intravenously every 3 weeks.
  • Gemcitabine — DRUG
    Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.
  • Cisplatin — DRUG
    Cisplatin administered intravenously on Day 1 of 21-day cycles.
  • Pemetrexed — DRUG
    Pemetrexed administered intravenously on Day 1 of 21-day cycles.
  • Carboplatin — DRUG
    Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
  • Paclitaxel — DRUG
    Paclitaxel administered intravenously on Day 1 of 21-day cycles.

Study Details

The purpose of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose of INCMGA00012 in combination with common standard-of-care chemotherapy regimens in participants with advanced solid tumors.

Key Dates

Start date
Jul 15, 2019
Status verified
Apr 2020
Primary completion
Nov 4, 2019
Completion
Nov 4, 2019

Study Design

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

Arms

  • Experimental: INCMGA00012 + gemcitabine/cisplatin
  • Experimental: INCMGA00012 + pemetrexed/cisplatin
  • Experimental: INCMGA00012 + pemetrexed/carboplatin
  • Experimental: INCMGA00012 + paclitaxel/carboplatin

Primary Outcome Measure

Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy [ Time Frame: Up to approximately 27 months ]