Advanced and/or Metastatic Solid TumorsPhase 1NCT03920839
INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
A Phase 1 study testing Retifanlimab, Gemcitabine and Cisplatin in people with Advanced and/or Metastatic Solid Tumors and Stage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung Cancer, run by Incyte Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- Retifanlimab, Gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2019to 4 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
About this study
Official title: 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.
- 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
- Being tested
- Retifanlimab, Gemcitabine, Cisplatin, Pemetrexed, Carboplatin
- Keywords
- solid tumors, non-small cell lung cancer, malignant pleural mesothelioma, chemotherapy, programmed cell death protein 1 (PD-1) inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Mesothelioma, Malignant, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetifanlimabDrug
Also called INCMGA00012
INCMGA00012 administered intravenously every 3 weeks.
GemcitabineDrug
Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.
CisplatinDrug
Cisplatin administered intravenously on Day 1 of 21-day cycles.
PemetrexedDrug
Pemetrexed administered intravenously on Day 1 of 21-day cycles.
CarboplatinDrug
Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
PaclitaxelDrug
Paclitaxel administered intravenously on Day 1 of 21-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| INCMGA00012 + gemcitabine/cisplatin | Experimental | Not described Receives: Drug: Retifanlimab; Drug: Gemcitabine; Drug: Cisplatin |
| INCMGA00012 + pemetrexed/cisplatin | Experimental | Not described Receives: Drug: Retifanlimab; Drug: Cisplatin; Drug: Pemetrexed |
| INCMGA00012 + pemetrexed/carboplatin | Experimental | Not described Receives: Drug: Retifanlimab; Drug: Pemetrexed; Drug: Carboplatin |
| INCMGA00012 + paclitaxel/carboplatin | Experimental | Not described Receives: Drug: Retifanlimab; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 27 months
Secondary outcomes (7)
Objective response rate (ORR)
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.
Measured: Through study completion, up to approximately 31 months
Duration of response (DOR)
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.
Measured: Through study completion, up to approximately 31 months
Disease control rate (DCR)
Defined as the number of participants with CR or PR as best response or stable disease that was maintained for at least 12 weeks.
Measured: Through study completion, up to approximately 31 months
Cmax of INCMGA00012 when given in combination with chemotherapy agents
Maximum observed plasma or serum concentration.
Measured: Through post-induction Cycle 5 Day 1, up to 15 weeks
Tmax of INCMGA00012 when given in combination with chemotherapy agents
Time to maximum concentration.
Measured: Through post-induction Cycle 5 Day 1, up to 15 weeks
Cmin of INCMGA00012 when given in combination with chemotherapy agents
Minimum observed plasma or serum concentration over the dose interval.
Measured: Through post-induction Cycle 5 Day 1, up to 15 weeks
AUC0-t of INCMGA00012 when given in combination with chemotherapy agents
Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Measured: Through post-induction Cycle 5 Day 1, up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start15 Jul 2019
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Why it stopped: As of November 4, 2019 the study was halted prematurely and will not resume.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced and/or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920839
- Sponsor's protocol ID
- INCMGA 0012-105
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
- ClinicalTrials.gov ID
- NCT03920839
- Acronym / sponsor ID
- INCMGA 0012-105
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: As of November 4, 2019 the study was halted prematurely and will not resume.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RetifanlimabAlso: INCMGA00012INCMGA00012 administered intravenously every 3 weeks. | Drug | INCMGA00012 + gemcitabine/cisplatin, INCMGA00012 + paclitaxel/carboplatin, INCMGA00012 + pemetrexed/carboplatin, INCMGA00012 + pemetrexed/cisplatin |
| GemcitabineGemcitabine administered intravenously on Days 1 and 8 of 21-day cycles. | Drug | INCMGA00012 + gemcitabine/cisplatin |
| CisplatinCisplatin administered intravenously on Day 1 of 21-day cycles. | Drug | INCMGA00012 + gemcitabine/cisplatin, INCMGA00012 + pemetrexed/cisplatin |
| PemetrexedPemetrexed administered intravenously on Day 1 of 21-day cycles. | Drug | INCMGA00012 + pemetrexed/carboplatin, INCMGA00012 + pemetrexed/cisplatin |
| CarboplatinCarboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles. | Drug | INCMGA00012 + paclitaxel/carboplatin, INCMGA00012 + pemetrexed/carboplatin |
| PaclitaxelPaclitaxel administered intravenously on Day 1 of 21-day cycles. | Drug | INCMGA00012 + paclitaxel/carboplatin |
Primary outcome
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.
7 secondary outcomes
Objective response rate (ORR)
Time frame: Through study completion, up to approximately 31 months
Duration of response (DOR)
Time frame: Through study completion, up to approximately 31 months
Disease control rate (DCR)
Time frame: 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
Tmax of INCMGA00012 when given in combination with chemotherapy agents
Time frame: 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
AUC0-t of INCMGA00012 when given in combination with chemotherapy agents
Time frame: Through post-induction Cycle 5 Day 1, up to 15 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Retifanlimab, Gemcitabine and Cisplatin in people with Advanced and/or Metastatic Solid Tumors and Stage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung Cancer, run by Incyte Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy (time frame: Up to approximately 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.