Unresectable or Metastatic Solid TumorsPhase 1NCT03589651
INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors
A Phase 1 study testing Retifanlimab, Epacadostat and INCB050465 in people with Unresectable or Metastatic Solid Tumors, run by Incyte Corporation at 9 sites in United States.
Trial summary
The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable or Metastatic Solid Tumors
- What is being tested?
- Retifanlimab, Epacadostat and INCB050465
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 Aug 2018to 21 Nov 2022
- 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
- Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or participants who are intolerant to or have declined standard therapy
- Measurable or nonmeasurable tumor lesions per RECIST v 1.1.
- Willing to provide fresh or archival tumor tissue for correlative studies.
- Eastern Cooperative Oncology Group performance status 0 to 1.
- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Who cannot join
- Receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy.
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support).
- Laboratory values outside the protocol-defined range at screening.
- Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids.
- Known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
- Evidence of interstitial lung disease or active, noninfectious pneumonitis.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Florida - Shands Cancer Center
Gainesville, Florida, 32610
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Rutgers Cancer Institute of Nj
New Brunswick, New Jersey, 08901
Yale New Haven Hospital
New Haven, Connecticut, 06510
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Upmc Cancercenter
Pittsburgh, Pennsylvania, 15232
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
Official title: A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.
- Conditions
- Unresectable or Metastatic Solid Tumors
- Being tested
- Retifanlimab, Epacadostat, INCB050465
- Keywords
- Solid tumors, locally advanced unresectable tumor, metastatic solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetifanlimabDrug
Part 1: INCMGA00012 at the protocol-defined starting dose administered intravenously every 4 weeks, with dose escalation to determine the maximum tolerated dose.
Part 2: INCMGA00012 at the recommended dose from Part 1.
EpacadostatDrug
Also called INCB024360, INCMGA00012
Part 1: Epacadostat at the protocol-defined starting dose administered orally twice daily, with dose escalation to determine the maximum tolerated dose.
Part 2: Epacadostat at the recommended dose from Part 1.
INCB050465Drug
Part 1: INCB050465 at the protocol-defined starting dose administered orally once daily, with dose escalation to determine the maximum tolerated dose. Part 2: INCB050465 at the recommended dose from Part 1.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | INCMGA00012 with epacadostat. Receives: Drug: Retifanlimab; Drug: Epacadostat |
| Group B | Experimental | INCMGA00012 with INCB050465. Receives: Drug: Retifanlimab; Drug: INCB050465 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measured: Up to approximately 30 months
Secondary outcomes (10)
Cmax of INCMGA00012 when given in combination with immune therapies
Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measured: Up to approximately 4 months
Tmax of INCMGA00012 when given in combination with immune therapies
Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measured: Up to approximately 4 months
Cmax of epacadostat when given in combination with INCMGA00012
Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measured: Up to approximately 4 months
Tmax of epacadostat when given in combination with INCMGA00012
Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measured: Up to approximately 4 months
Cmax of INCB050645 when given in combination with INCMGA00012
Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measured: Up to approximately 4 months
Tmax of INCB050645 when given in combination with INCMGA00012
Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measured: Up to approximately 4 months
Overall response rate
Defined as the percentage of participants having complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST v1.1 for immune-based therapeutics.
Measured: Up to approximately 30 months
Duration of response
Defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met or date of death due to any cause, whichever occurs first.
Measured: Up to approximately 30 months
Progression-free survival
Defined as the time from the start of therapy until the earliest date at which progression criteria are met or date of death due to any cause, whichever occurs first.
Measured: Up to approximately 30 months
Overall survival
Defined as the time from randomization to death due to any cause.
Measured: Up to approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start17 Aug 2018
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589651
- Sponsor's protocol ID
- INCMGA 0012-102
- Status last verified
- Feb 2023
- First submitted
- 5 Jul 2018
- Last updated
- 21 Feb 2023
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03589651
- Acronym / sponsor ID
- INCMGA 0012-102
- Conditions
- Unresectable or Metastatic Solid Tumors
- Keywords
- Solid tumors, locally advanced unresectable tumor, metastatic solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 18 Jul 2018 (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 determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Retifanlimab, Drug: EpacadostatINCMGA00012 with epacadostat. |
| Group B | Experimental | Drug: Retifanlimab, Drug: INCB050465INCMGA00012 with INCB050465. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or participants who are intolerant to or have declined standard therapy
- Measurable or nonmeasurable tumor lesions per RECIST v 1.1.
- Willing to provide fresh or archival tumor tissue for correlative studies.
- Eastern Cooperative Oncology Group performance status 0 to 1.
- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Key exclusion criteria (6 listed)
- Receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy.
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support).
- Laboratory values outside the protocol-defined range at screening.
- Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids.
- Known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
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 |
|---|---|---|
| RetifanlimabPart 1: INCMGA00012 at the protocol-defined starting dose administered intravenously every 4 weeks, with dose escalation to determine the maximum tolerated dose. Part 2: INCMGA00012 at the recommended dose from Part 1. | Drug | Group A, Group B |
| EpacadostatAlso: INCB024360, INCMGA00012Part 1: Epacadostat at the protocol-defined starting dose administered orally twice daily, with dose escalation to determine the maximum tolerated dose. Part 2: Epacadostat at the recommended dose from Part 1. | Drug | Group A |
| INCB050465Part 1: INCB050465 at the protocol-defined starting dose administered orally once daily, with dose escalation to determine the maximum tolerated dose. Part 2: INCB050465 at the recommended dose from Part 1. | Drug | Group B |
Primary outcome
Number of treatment-emergent adverse events
Time frame: Up to approximately 30 months
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
10 secondary outcomes
Cmax of INCMGA00012 when given in combination with immune therapies
Time frame: Up to approximately 4 months
Tmax of INCMGA00012 when given in combination with immune therapies
Time frame: Up to approximately 4 months
Cmax of epacadostat when given in combination with INCMGA00012
Time frame: Up to approximately 4 months
Tmax of epacadostat when given in combination with INCMGA00012
Time frame: Up to approximately 4 months
Cmax of INCB050645 when given in combination with INCMGA00012
Time frame: Up to approximately 4 months
Tmax of INCB050645 when given in combination with INCMGA00012
Time frame: Up to approximately 4 months
Overall response rate
Time frame: Up to approximately 30 months
Duration of response
Time frame: Up to approximately 30 months
Progression-free survival
Time frame: Up to approximately 30 months
Overall survival
Time frame: Up to approximately 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Retifanlimab, Epacadostat and INCB050465 in people with Unresectable or Metastatic Solid Tumors, run by Incyte Corporation at 9 sites in United States.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Up to approximately 30 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 21 Feb 2023.