- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03920839
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Withdrawn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
|
INCMGA00012 administered intravenously every 3 weeks.
Other Names:
Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.
Cisplatin administered intravenously on Day 1 of 21-day cycles.
|
Experimental: INCMGA00012 + pemetrexed/cisplatin
|
INCMGA00012 administered intravenously every 3 weeks.
Other Names:
Cisplatin administered intravenously on Day 1 of 21-day cycles.
Pemetrexed administered intravenously on Day 1 of 21-day cycles.
|
Experimental: INCMGA00012 + pemetrexed/carboplatin
|
INCMGA00012 administered intravenously every 3 weeks.
Other Names:
Pemetrexed administered intravenously on Day 1 of 21-day cycles.
Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
|
Experimental: INCMGA00012 + paclitaxel/carboplatin
|
INCMGA00012 administered intravenously every 3 weeks.
Other Names:
Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
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
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
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Mesothelioma
- Mesothelioma, Malignant
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Folic Acid Antagonists
- Gemcitabine
- Carboplatin
- Paclitaxel
- Cisplatin
- Pemetrexed
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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