Clinical trial · Interventional
INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
NCT03920839CI-TRIAL-00044810withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): As of November 4, 2019 the study was halted prematurely and will not resume.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced and/or Metastatic Solid Tumors | — | UNRESOLVED | — |
| Advanced/Metastatic Unresectable Malignant Pleural Mesothelioma | — | UNRESOLVED | — |
| Stage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Retifanlimab | Drug | Retifanlimab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- INCMGA00012 + gemcitabine/cisplatin
- interventionNames
- Drug: Retifanlimab
- Drug: Gemcitabine
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- INCMGA00012 + pemetrexed/cisplatin
- interventionNames
- Drug: Retifanlimab
- Drug: Cisplatin
- Drug: Pemetrexed
- type
- EXPERIMENTAL
- label
- INCMGA00012 + pemetrexed/carboplatin
- interventionNames
- Drug: Retifanlimab
- Drug: Pemetrexed
- Drug: Carboplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.