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

April 21, 2020 updated by: Incyte Corporation

A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INCMGA00012 + gemcitabine/cisplatin
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.
Other Names:
  • INCMGA00012
Drug: Gemcitabine
Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.
Drug: Cisplatin
Cisplatin administered intravenously on Day 1 of 21-day cycles.
Experimental: INCMGA00012 + pemetrexed/cisplatin
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.
Other Names:
  • INCMGA00012
Drug: Cisplatin
Cisplatin administered intravenously on Day 1 of 21-day cycles.
Drug: Pemetrexed
Pemetrexed administered intravenously on Day 1 of 21-day cycles.
Experimental: INCMGA00012 + pemetrexed/carboplatin
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.
Other Names:
  • INCMGA00012
Drug: Pemetrexed
Pemetrexed administered intravenously on Day 1 of 21-day cycles.
Drug: Carboplatin
Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
Experimental: INCMGA00012 + paclitaxel/carboplatin
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.
Other Names:
  • INCMGA00012
Drug: Carboplatin
Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
Drug: Paclitaxel
Paclitaxel administered intravenously on Day 1 of 21-day cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy
Time Frame: Up to approximately 27 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Through study completion, up to approximately 31 months
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.
Through study completion, up to approximately 31 months
Duration of response (DOR)
Time Frame: Through study completion, up to approximately 31 months
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.
Through study completion, up to approximately 31 months
Disease control rate (DCR)
Time Frame: Through study completion, up to approximately 31 months
Defined as the number of participants with CR or PR as best response or stable disease that was maintained for at least 12 weeks.
Through study completion, up to approximately 31 months
Cmax of INCMGA00012 when given in combination with chemotherapy agents
Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks
Maximum observed plasma or serum concentration.
Through post-induction Cycle 5 Day 1, up to 15 weeks
Tmax of INCMGA00012 when given in combination with chemotherapy agents
Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks
Time to maximum concentration.
Through post-induction Cycle 5 Day 1, up to 15 weeks
Cmin of INCMGA00012 when given in combination with chemotherapy agents
Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks
Minimum observed plasma or serum concentration over the dose interval.
Through post-induction Cycle 5 Day 1, up to 15 weeks
AUC0-t of INCMGA00012 when given in combination with chemotherapy agents
Time Frame: Through post-induction Cycle 5 Day 1, up to 15 weeks
Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Through post-induction Cycle 5 Day 1, up to 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Actual)

November 4, 2019

Study Completion (Actual)

November 4, 2019

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 21, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCMGA 0012-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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