Description:
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.
Title
- Brief Title: INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
- Official Title: A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
Clinical Trial IDs
- ORG STUDY ID:
INCMGA 0012-105
- NCT ID:
NCT03920839
Conditions
- Advanced and/or Metastatic Solid Tumors
- Stage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung Cancer
- Advanced/Metastatic Unresectable Malignant Pleural Mesothelioma
Interventions
Drug | Synonyms | Arms |
---|
Retifanlimab | INCMGA00012 | INCMGA00012 + gemcitabine/cisplatin |
Gemcitabine | | INCMGA00012 + gemcitabine/cisplatin |
Cisplatin | | INCMGA00012 + gemcitabine/cisplatin |
Pemetrexed | | INCMGA00012 + pemetrexed/carboplatin |
Carboplatin | | INCMGA00012 + paclitaxel/carboplatin |
Paclitaxel | | INCMGA00012 + paclitaxel/carboplatin |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
INCMGA00012 + gemcitabine/cisplatin | Experimental | | - Retifanlimab
- Gemcitabine
- Cisplatin
|
INCMGA00012 + pemetrexed/cisplatin | Experimental | | - Retifanlimab
- Cisplatin
- Pemetrexed
|
INCMGA00012 + pemetrexed/carboplatin | Experimental | | - Retifanlimab
- Pemetrexed
- Carboplatin
|
INCMGA00012 + paclitaxel/carboplatin | Experimental | | - Retifanlimab
- Carboplatin
- Paclitaxel
|
Eligibility Criteria
Inclusion Criteria:
- Advanced and/or metastatic solid tumors including the following: histologically or
cytologically confirmed diagnosis of Stage IIIB not amenable to curative treatment or
Stage IV non-small cell lung cancer (pemetrexed-platinum treatment groups must have
nonsquamous histology type); and histologically or cytologically confirmed diagnosis
of advanced/metastatic unresectable malignant pleural mesothelioma.
- No prior systemic treatment with the following exceptions: participants with a known
sensitizing mutation (eg, BRAF, EGFR, ALK, or ROS1) should have had disease
progression on or following an approved targeted tyrosine kinase inhibitor; and
participants who received adjuvant or neoadjuvant chemotherapy are eligible if the
adjuvant/neoadjuvant therapy was completed at least 6 months before the date of
enrollment.
- Measurable or nonmeasurable tumor lesions per RECIST v1.1.
- Eastern Cooperative Oncology Group performance status 0 to 1.
Exclusion Criteria:
- Received prior treatment with checkpoint inhibitor agents (such as anti-PD-1,
anti-PD-L1, anti-PD-L2, or anti-CTLA-4).
- Had major surgery within 3 weeks before the first dose of study treatment.
- Received radiation therapy to the lung(s) that is > 30 Gy within 6 months of the first
dose of study treatment.
- Received palliative radiotherapy within 7 days before the first dose of study
treatment.
- Has ≥ Grade 2 residual toxicities from the most recent prior therapy (except
alopecia).
- Organ function (renal, hepatic), bone marrow reserve, and coagulation panel outside
the protocol-defined laboratory values.
- Is currently participating and receiving investigational therapy or has participated
in a study of an investigational agent and received study therapy or used an
investigational device within 4 weeks before the first dose of study treatment.
- Has active autoimmune disease requiring systemic immunosuppression with
corticosteroids (> 10 mg once daily of prednisone or equivalent) or immunosuppressive
drugs within 2 years before the first dose of study treatment.
- Is on chronic systemic steroids (> 10 mg once daily of prednisone or equivalent).
- Known active central nervous system metastases and/or carcinomatous meningitis
(patients with previously-treated and clinically stable brain metastases are eligible
and a washout period of ≥ 4 weeks since radiation therapy is required).
- Known additional malignancy that is progressing or requires active treatment.
- Evidence of interstitial lung disease or active, noninfectious pneumonitis.
- History of organ transplant, including allogeneic stem cell transplantation.
- Active infections requiring systemic antibiotics.
- Known active hepatitis B or C.
- Has a diagnosis of immunodeficiency, including participants known to be HIV positive
(positive for HIV 1/2 antibodies).
- Significant cardiac event within 6 months before Cycle 1 Day 1.
- Has received a live vaccine within 28 days of the planned start of study treatment.
- Known hypersensitivity to any component of the study drugs, excipients, or another
monoclonal antibody which cannot be controlled with standard measures (eg,
antihistamines and corticosteroids).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy |
Time Frame: | Up to approximately 27 months |
Safety Issue: | |
Description: | Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment. |
Secondary Outcome Measures
Measure: | Objective response rate (ORR) |
Time Frame: | Through study completion, up to approximately 31 months |
Safety Issue: | |
Description: | Defined as the percentage of participants having complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by investigator assessment. |
Measure: | Duration of response (DOR) |
Time Frame: | Through study completion, up to approximately 31 months |
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 investigator assessment or death due to any cause. |
Measure: | Disease control rate (DCR) |
Time Frame: | Through study completion, up to approximately 31 months |
Safety Issue: | |
Description: | Defined as the number of participants with CR or PR as best response or stable disease that was maintained for at least 12 weeks. |
Measure: | Cmax of INCMGA00012 when given in combination with chemotherapy agents |
Time Frame: | Through post-induction Cycle 5 Day 1, up to 15 weeks |
Safety Issue: | |
Description: | Maximum observed plasma or serum concentration. |
Measure: | Tmax of INCMGA00012 when given in combination with chemotherapy agents |
Time Frame: | Through post-induction Cycle 5 Day 1, up to 15 weeks |
Safety Issue: | |
Description: | Time to maximum concentration. |
Measure: | Cmin of INCMGA00012 when given in combination with chemotherapy agents |
Time Frame: | Through post-induction Cycle 5 Day 1, up to 15 weeks |
Safety Issue: | |
Description: | Minimum observed plasma or serum concentration over the dose interval. |
Measure: | AUC0-t of INCMGA00012 when given in combination with chemotherapy agents |
Time Frame: | Through post-induction Cycle 5 Day 1, up to 15 weeks |
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 1 |
Primary Purpose: | Interventional |
Overall Status: | Withdrawn |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- solid tumors
- non-small cell lung cancer
- malignant pleural mesothelioma
- chemotherapy
- programmed cell death protein 1 (PD-1) inhibitor
Last Updated
April 24, 2020