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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

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

Clinicaltrials.gov identifier NCT03920839

Recruitment Status Withdrawn (As of November 4, 2019 the study was halted prematurely and will not resume.)

First Posted April 19, 2019

Last update posted April 24, 2020

Study Description

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.

  • Condition or Disease: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/Treatment: Drug: Retifanlimab
    Drug: Gemcitabine
    Drug: Cisplatin
    Drug: Pemetrexed
    Drug: Carboplatin
    Drug: Paclitaxel
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
  • Actual Study Start Date: July 2019
  • Actual Primary Completion Date: November 2019
  • Actual Study Completion Date: November 2019
Arms and interventions
Arm Intervention/treatment
Experimental: INCMGA00012 + gemcitabine/cisplatin
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.

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 + paclitaxel/carboplatin
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.

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.
Experimental: INCMGA00012 + pemetrexed/carboplatin
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.

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 + pemetrexed/cisplatin
Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks.

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

Drug: Pemetrexed
Pemetrexed administered intravenously on Day 1 of 21-day cycles.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 5. 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.
  • 6. 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.
  • 7. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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).

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director: Incyte Medical Monitor Incyte Corporation

More Information
  • Responsible Party: Incyte Corporation
  • ClinicalTrials.gov Identifier: NCT03920839 History of Changes
  • Other Study ID Numbers: INCMGA 0012-105
  • First Posted: April 19, 2019 Key Record Dates
  • Last Update Posted: April 24, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Incyte Corporation: solid tumors
    non-small cell lung cancer
    malignant pleural mesothelioma
    chemotherapy
    programmed cell death protein 1 (PD-1) inhibitor
  • Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung Mesothelioma