INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)

NCT03920839 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: INCMGA 0012-105
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Keywords

solid tumors; non-small cell lung cancer; malignant pleural mesothelioma; chemotherapy; programmed cell death protein 1 (PD-1) inhibitor

Outcome Measures

Primary Outcomes (1)

• Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy

  Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment.

  Up to approximately 27 months

Secondary Outcomes (7)

• Objective response rate (ORR)

  Through study completion, up to approximately 31 months

• Duration of response (DOR)

  Through study completion, up to approximately 31 months

• Disease control rate (DCR)

  Through study completion, up to approximately 31 months

• Cmax of INCMGA00012 when given in combination with chemotherapy agents

  Through post-induction Cycle 5 Day 1, up to 15 weeks

• Tmax of INCMGA00012 when given in combination with chemotherapy agents

  Through post-induction Cycle 5 Day 1, up to 15 weeks

Study Arms (4)

INCMGA00012 + gemcitabine/cisplatin

EXPERIMENTAL

Drug: Retifanlimab; Drug: Gemcitabine; Drug: Cisplatin

INCMGA00012 + pemetrexed/cisplatin

EXPERIMENTAL

Drug: Retifanlimab; Drug: Cisplatin; Drug: Pemetrexed

INCMGA00012 + pemetrexed/carboplatin

EXPERIMENTAL

Drug: Retifanlimab; Drug: Pemetrexed; Drug: Carboplatin

INCMGA00012 + paclitaxel/carboplatin

EXPERIMENTAL

Drug: Retifanlimab; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Retifanlimab DRUG

INCMGA00012 administered intravenously every 3 weeks.

Also known as: INCMGA00012

INCMGA00012 + gemcitabine/cisplatin; INCMGA00012 + paclitaxel/carboplatin; INCMGA00012 + pemetrexed/carboplatin; INCMGA00012 + pemetrexed/cisplatin

Gemcitabine DRUG

Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.

INCMGA00012 + gemcitabine/cisplatin

Cisplatin DRUG

Cisplatin administered intravenously on Day 1 of 21-day cycles.

INCMGA00012 + gemcitabine/cisplatin; INCMGA00012 + pemetrexed/cisplatin

Pemetrexed DRUG

Pemetrexed administered intravenously on Day 1 of 21-day cycles.

INCMGA00012 + pemetrexed/carboplatin; INCMGA00012 + pemetrexed/cisplatin

Carboplatin DRUG

Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.

INCMGA00012 + paclitaxel/carboplatin; INCMGA00012 + pemetrexed/carboplatin

Paclitaxel DRUG

Paclitaxel administered intravenously on Day 1 of 21-day cycles.

INCMGA00012 + paclitaxel/carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Gemcitabine; Cisplatin; Pemetrexed; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Pleural Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: July 15, 2019
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share