Tracking Information

First Submitted Date ^ICMJE

April 17, 2019

First Posted Date ^ICMJE

April 19, 2019

Last Update Posted Date

April 24, 2020

Actual Study Start Date ^ICMJE

July 15, 2019

Actual Primary Completion Date

November 4, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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.
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.
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.
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.
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.
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.
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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.

Other Name: 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.
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.
Drug: Paclitaxel
Paclitaxel administered intravenously on Day 1 of 21-day cycles.

Study Arms ^ICMJE

Experimental: INCMGA00012 + gemcitabine/cisplatin
Interventions:
- Drug: Retifanlimab
- Drug: Gemcitabine
- Drug: Cisplatin
Experimental: INCMGA00012 + pemetrexed/cisplatin
Interventions:
- Drug: Retifanlimab
- Drug: Cisplatin
- Drug: Pemetrexed
Experimental: INCMGA00012 + pemetrexed/carboplatin
Interventions:
- Drug: Retifanlimab
- Drug: Pemetrexed
- Drug: Carboplatin
Experimental: INCMGA00012 + paclitaxel/carboplatin
Interventions:
- Drug: Retifanlimab
- Drug: Carboplatin
- Drug: Paclitaxel

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Actual Enrollment ^ICMJE

0

Original Estimated Enrollment ^ICMJE

96

Actual Study Completion Date ^ICMJE

November 4, 2019

Actual Primary Completion Date

November 4, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

No

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

United States

Administrative Information

NCT Number ^ICMJE

NCT03920839

Other Study ID Numbers ^ICMJE

INCMGA 0012-105

Has Data Monitoring Committee

No

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

No

Responsible Party

Incyte Corporation

Study Sponsor ^ICMJE

Incyte Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Incyte Medical Monitor

Incyte Corporation

PRS Account

Incyte Corporation

Verification Date

April 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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

study details

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