Advanced or Metastatic Solid MalignanciesPhase 2/3NCT04887870
Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study
A Phase 2/3 study testing Sitravatinib, Nivolumab and Pembrolizumab in people with Advanced or Metastatic Solid Malignancies, run by Mirati Therapeutics Inc. at 13 sites in United States.
Trial summary
A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Malignancies
- What is being tested?
- Sitravatinib, Nivolumab and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 13 sitesUnited States
- Study dates
- 29 Jun 2021to 25 Sep 2025
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol
- Currently tolerating the treatment regimen in the parent protocol
- Experiencing clinical benefit with or without prior radiographic progression from the treatment regimen in the parent protocol in the opinion of the investigator and the investigator determines that continuing treatment is in the patient's best interest
Who cannot join
- Known or suspected presence of other cancer
- Other life- threatening illness or organ system dysfunction compromising safety evaluation
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Local Institution - 516-014-011
Albany, New York, 12208
Local Institution - 516-014-001
Austin, Texas, 78758
Local Institution - 516-014-002
Boston, Massachusetts, 02215
Local Institution - 516-014-004
Columbus, Ohio, 43210
USOR - Texas Oncology Northeast Texas - Denison
Denison, Texas, 75020
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
NEXT Virginia
Fairfax, Virginia, 22031
Local Institution - 516-014-029
Goshen, Indiana, 46526
Local Institution - 516-014-013
Houston, Texas, 77030
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, 80218
Local Institution - 516-014-005
Minneapolis, Minnesota, 55455
Memorial Sloan Kettering Cancer Center - Arnold and Marie Schwartz Cancer Research Building
New York, New York, 10065
Urology Cancer Center and GU Research Network
Omaha, Nebraska, 68130
About this study
Official title: A Multicenter, Open-label Rollover Study of Sitravatinib Alone or in Combination With Other Anticancer Therapies in Patients With Advanced or Metastatic Solid Malignancies
A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies
Read the detailed description
Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and MET.
The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
- Being tested
- Sitravatinib, Nivolumab, Pembrolizumab, Enfortumab Vedotin-Ejfv, Ipilimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitravatinibDrug
Also called MGCD516
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
NivolumabDrug
Also called OPDIVO
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
PembrolizumabDrug
Also called KEYTRUDA
Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
Enfortumab Vedotin-EjfvDrug
Also called PADCEV
Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)
IpilimumabDrug
Also called YERVOY
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
| Study group | Role | What they receive |
|---|---|---|
| Phase 2/3: Open label extension of parent study | Experimental | The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial. Receives: Drug: Sitravatinib; Drug: Nivolumab; Drug: Pembrolizumab; Drug: Enfortumab Vedotin-Ejfv; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Related Adverse Events.
An AE is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Assessment of AEs will include type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 5.0]), timing, seriousness, and relatedness to study treatment. A treatment-emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any pre-existing condition that increases in severity after the first dose of study treatment.
Measured: Approximately up to 80.5 weeks
Number of Participants With Treatment Related Adverse Events Which Lead to Study Drug Discontinuation
Number of participants with treatment related adverse events which lead to study drug discontinuation.
Measured: Approximately up to 80.5 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
An abnormal laboratory test result should be reported as an AE in the CRF only if it is associated with one or more of the following:
- Clinical symptoms;
- Requires additional tests (beyond repeats), treatment, or intervention;
- Results in change in study treatment dosing;
- Requires discontinuation from study treatment; and/or
- Considered by the investigator or sponsor to be an AE.
Measured: Approximately up to 80.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start29 Jun 2021
- Primary completion21 Apr 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced or Metastatic Solid MalignanciesStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887870
- Sponsor's protocol ID
- CA248-0003
- Other IDs
- CA248-0003, 516-014
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2021
- Last updated
- 4 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Rollover Study of Sitravatinib Alone or in Combination With Other Anticancer Therapies in Patients With Advanced or Metastatic Solid Malignancies
- ClinicalTrials.gov ID
- NCT04887870
- Acronym / sponsor ID
- CA248-0003
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Posted 4 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies
Detailed description
Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and MET.
The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 2/3: Open label extension of parent study | Experimental | Drug: Sitravatinib, Drug: Nivolumab, Drug: Pembrolizumab, Drug: Enfortumab Vedotin-Ejfv, Drug: IpilimumabThe current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol
- Currently tolerating the treatment regimen in the parent protocol
- Experiencing clinical benefit with or without prior radiographic progression from the treatment regimen in the parent protocol in the opinion of the investigator and the investigator determines that continuing treatment is in the patient's best interest
Key exclusion criteria (2 listed)
- Known or suspected presence of other cancer
- Other life- threatening illness or organ system dysfunction compromising safety evaluation
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 |
|---|---|---|
| SitravatinibAlso: MGCD516Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases. | Drug | Phase 2/3: Open label extension of parent study |
| NivolumabAlso: OPDIVONivolumab is a programmed death receptor-1 (PD-1) blocking antibody | Drug | Phase 2/3: Open label extension of parent study |
| PembrolizumabAlso: KEYTRUDAPembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody | Drug | Phase 2/3: Open label extension of parent study |
| Enfortumab Vedotin-EjfvAlso: PADCEVEnfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE) | Drug | Phase 2/3: Open label extension of parent study |
| IpilimumabAlso: YERVOYIpilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody | Drug | Phase 2/3: Open label extension of parent study |
Primary outcome
Number of Participants With Treatment Related Adverse Events.
Time frame: Approximately up to 80.5 weeks
An AE is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Assessment of AEs will include type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 5.0]), timing, seriousness, and relatedness to study treatment. A treatment-emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any pre-existing condition that increases in severity after the first dose of study treatment.
Number of Participants With Treatment Related Adverse Events Which Lead to Study Drug Discontinuation
Time frame: Approximately up to 80.5 weeks
Number of participants with treatment related adverse events which lead to study drug discontinuation.
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Approximately up to 80.5 weeks
An abnormal laboratory test result should be reported as an AE in the CRF only if it is associated with one or more of the following: * Clinical symptoms; * Requires additional tests (beyond repeats), treatment, or intervention; * Results in change in study treatment dosing; * Requires discontinuation from study treatment; and/or * Considered by the investigator or sponsor to be an AE.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sitravatinib, Nivolumab and Pembrolizumab in people with Advanced or Metastatic Solid Malignancies, run by Mirati Therapeutics Inc. at 13 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 3 inclusion and 2 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Treatment Related Adverse Events. (time frame: Approximately up to 80.5 weeks). The study lists 3 primary outcomes in all. 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 4 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.