Description:
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in
participants with advanced/metastatic Merkel cell carcinoma (MCC).
Title
- Brief Title: A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
- Official Title: A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)
Clinical Trial IDs
- ORG STUDY ID:
INCMGA 0012-201
- NCT ID:
NCT03599713
Conditions
- Metastatic Merkel Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Retifanlimab | MGA012, INCMGA00012 | INCMGA00012 |
Purpose
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in
participants with advanced/metastatic Merkel cell carcinoma (MCC).
Trial Arms
Name | Type | Description | Interventions |
---|
INCMGA00012 | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent.
- Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional
disease not amenable to surgery or radiation
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Measurable disease according to RECIST v1.1.
- Availability of tumor tissue (fresh or archival) for central pathology review.
- Willingness to avoid pregnancy or fathering children based on protocol-defined
criteria.
Exclusion Criteria:
- Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or
PD-L1-directed therapy.
- Treatment with anticancer drugs or participation in another interventional clinical
study within 21 days before the first administration of study drug.
- Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (with
the exceptions for anemia not requiring transfusion support and any grade of alopecia)
and/or complications from prior surgical intervention within 7 days before starting
study treatment.
- Radiation therapy administered within 2 weeks of first dose of study treatment or
radiation therapy to the thoracic region that is > 30 Gy within 6 months of the first
dose of study treatment.
- Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- History of second malignancy within 3 years (with exceptions).
- Laboratory values outside the protocol-defined range at screening.
- Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
- Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
- Receipt of a live vaccine within 28 days of planned start of study therapy.
- Current use of protocol-defined prohibited medication.
- Known hypersensitivity to another monoclonal antibody that cannot be controlled with
standard measures (eg, antihistamines and corticosteroids).
- Inability or unlikely, in the opinion of the investigator, to comply with the Protocol
requirements.
- Participant who is pregnant or breastfeeding.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Response Rate (ORR) |
Time Frame: | Baseline up to approximately 8 months |
Safety Issue: | |
Description: | Defined as the percentage of participants with an objective response (complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by independent central radiographic review (ICR). |
Secondary Outcome Measures
Measure: | Duration of Response (DOR) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression as determined by ICR or death due to any cause. |
Measure: | Disease Control Rate (DCR) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the proportion of participants with either an objective response or stable disease lasting at least 6 months. |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the time from the start of therapy until disease progression as determined by the ICR or death due to any cause. |
Measure: | Overall survival (OS) |
Time Frame: | Up to approximately 2 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 (TEAE) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment. |
Measure: | Cmax of INCMGA00012 |
Time Frame: | Up to approximately 6 months |
Safety Issue: | |
Description: | Maximum observed serum concentration. |
Measure: | tmax of INCMGA00012 |
Time Frame: | Up to approximately 6 months |
Safety Issue: | |
Description: | Time to maximum concentration. |
Measure: | Cmin of INCMGA00012 |
Time Frame: | Up to approximately 6 months |
Safety Issue: | |
Description: | Minimum observed serum concentration over the dose interval. |
Measure: | AUCt of INCMGA00012 |
Time Frame: | Up to approximately 6 months |
Safety Issue: | |
Description: | Area under the serum concentration-time curve. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Metastatic merkel cell carcinoma
- anti-PD-1 antibody
- immunoglobulin G4 (IgG4) monoclonal antibody
- INCMGA00012
Last Updated
November 4, 2020