A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)

Part of paid clinical trials in Fresno, California.

Sponsor
Incyte Corporation
Study ID
NCT03679767
Phase
PHASE2
Status
Completed

Conditions

  • Locally Advanced Renal Cell Carcinoma
  • Locally Advanced Urothelial Cancer
  • Metastatic Clear-Cell Renal Cell Carcinoma
  • Metastatic Melanoma
  • Metastatic Non-small Cell Lung Cancer
  • Metastatic Urothelial Cancer
  • Unresectable Melanoma

Eligibility Criteria

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

Interventions

  • Retifanlimab — DRUG
    Retifanlimab administered intravenously at 500 mg every 4 weeks

Study Details

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.

Key Dates

Start date
Jan 9, 2019
Status verified
Jul 2023
Primary completion
Apr 15, 2021
Completion
Jun 28, 2022

Study Design

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

Arms

  • Experimental: Melanoma: retifanlimab 500 mg
    Participants with melanoma received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle.
  • Experimental: NSCLC: retifanlimab 500 mg
    Participants with non-small cell lung cancer (NSCLC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.
  • Experimental: UC: retifanlimab 500 mg
    Participants with urethelial carcinoma (UC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.
  • Experimental: RCC: retifanlimab 500 mg
    Participants with renal cell carcinoma (RCC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: up to 25.9 months ]

Locations (18)

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