Description:
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.
Title
- Brief Title: A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
- Official Title: A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)
Clinical Trial IDs
- ORG STUDY ID:
INCMGA 0012-203
- NCT ID:
NCT03679767
Conditions
- Metastatic Non-small Cell Lung Cancer
- Locally Advanced Urothelial Cancer
- Metastatic Urothelial Cancer
- Unresectable Melanoma
- Metastatic Melanoma
- Locally Advanced Renal Cell Carcinoma
- Metastatic Clear-Cell Renal Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Retifanlimab | INCMGA00012 | INCMGA00012 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
INCMGA00012 | Experimental | INCMGA00012 administered to cohorts of specific tumor types. | |
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of one of the following: treatment-naïve metastatic non-small cell
lung cancer with high PD-L1 expression (tumor proportion score ≥ 50%) and no epidermal
growth factor receptor (EGFR), alkaline phosphatase (ALK), or ROS activating genomic
tumor aberrations; locally advanced or metastatic urothelial carcinoma in participants
who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a
combined positive score ≥ 10; unresectable or metastatic melanoma; locally advanced or
metastatic renal cell carcinoma with clear cell component (with or without sarcomatoid
features) and having received no prior systemic therapy.
- Measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group performance status 0 to 1.
- Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
- Receipt of anticancer therapy or participation in another interventional clinical
study within 21 days before the first administration of study drug.
- Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be
acceptable with prior approval from the medical monitor).
- Radiotherapy within 14 days of first dose of study treatment with the following
caveats: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy
that is > 30 Gy.
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the
exception of anemia not requiring transfusion support and any grade of alopecia).
Endocrinopathy, if well-managed, is not exclusionary and should be discussed with
sponsor medical monitor.
- Has not recovered adequately from toxicities and/or complications from surgical
intervention before starting study drug.
- Laboratory values outside the protocol-defined range at screening.
- Known additional malignancy that is progressing or requires active treatment, or
history of other malignancy within 3 years of study entry.
- Active autoimmune disease requiring systemic immunosuppression in excess of
physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or
equivalent).
- Evidence of interstitial lung disease or active noninfectious pneumonitis.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Known active hepatitis B antigen, hepatitis B virus, or hepatitis C virus infection.
- Active infections requiring systemic therapy.
- Known to be HIV-positive, unless all of the following criteria are met: CD4+ count ≥
300/μL, undetectable viral load, receiving antiretroviral therapy.
- Known hypersensitivity to another monoclonal antibody that cannot be controlled with
standard measures (eg, antihistamines and corticosteroids).
- Impaired cardiac function or clinically significant cardiac disease.
- Is pregnant or breastfeeding.
- Has received a live vaccine within 28 days of the planned start of study drug.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall response rate |
Time Frame: | Up to at least 6 months from the start of treatment |
Safety Issue: | |
Description: | Defined as the percentage of participants having a complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the investigator. |
Secondary Outcome Measures
Measure: | Duration of response |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until first observation of documented disease progression as determined by investigator or death due to any cause. |
Measure: | Disease control rate |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Defined as the proportion of participants with either an objective response (CR and PR) or stable disease, according to RECIST v1.1. |
Measure: | Progression-free survival |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Defined as the time from the start of therapy until disease progression, as determined by investigator or death due to any cause. |
Measure: | Overall survival |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Defined as the time from the start of therapy until death due to any cause. |
Measure: | Number of treatment-emergent adverse events |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug. |
Measure: | Cmax of INCMGA00012 |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Maximum observed plasma or serum concentration. |
Measure: | Tmax of INCMGA00012 |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Time to maximum concentration. |
Measure: | Cmin of INCMGA00012 |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Minimum observed plasma or serum concentration over the dose interval. |
Measure: | AUC0-t of INCMGA00012 |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- PD-1inhibitor
- non-small cell lung cancer
- urothelial cancer
- melanoma
- renal cell carcinoma
Last Updated
February 5, 2021