Sitravatinib Combination Therapy for Solid Cancers

No longer recruiting at 30 trial locations

Overseen By Mirati Therapeutics Study Locator Services

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Mirati Therapeutics Inc.

Must be taking: Sitravatinib

Disqualifiers: Other cancer, Life-threatening illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the drug sitravatinib, alone or with other cancer treatments, to evaluate its effects on solid tumors that have spread or are difficult to treat. The goal is to determine the safety and effectiveness of these treatments for individuals already benefiting from sitravatinib in another trial. Ideal candidates for this trial are those currently participating in another study with sitravatinib, experiencing positive effects without major side effects. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. It offers a promising opportunity for patients to contribute to advancing cancer treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it seems you need to be already receiving sitravatinib or a combination therapy in another related study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sitravatinib is generally safe for most people. Studies indicate that most side effects are mild to moderate. Common side effects include diarrhea (loose stools), fatigue, and high blood pressure. When combined with other cancer treatments, sitravatinib remains manageable. While some side effects might occur, they can often be addressed with proper care. Overall, sitravatinib appears well-tolerated, but discussing potential side effects with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Sitravatinib is unique because it targets multiple pathways involved in cancer cell growth and survival, which is different from many current treatments that often focus on a single pathway. Researchers are excited because sitravatinib can be combined with other anticancer therapies to potentially enhance their effectiveness, offering a more comprehensive approach to treating solid tumors. This multi-target strategy may lead to better outcomes for patients who haven't responded well to standard treatments.

What evidence suggests that sitravatinib combination therapy could be effective for solid cancers?

Research has shown that sitravatinib may help treat solid tumors. In earlier studies, 68.9% of patients experienced a reduction in tumor size, and 61.5% had stable disease. The treatment proved most effective in patients with specific genetic markers. Sitravatinib was generally safe, with manageable side effects. This trial tests sitravatinib alongside other cancer therapies to determine its effectiveness in patients with advanced or spreading cancers. ^{1 2 6 7 8}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for patients already benefiting from Sitravatinib alone or with other cancer drugs in a previous study, without severe side effects or another life-threatening illness. The doctor must believe continuing treatment is good for the patient.

Inclusion Criteria

You are currently taking sitravatinib alone or with other medications in another study sponsored by Mirati.

Currently tolerating the treatment regimen in the parent protocol

You are currently receiving treatment that is helping you, and your doctor thinks it's best to continue this treatment.

Exclusion Criteria

I may have another type of cancer besides the one being treated.

I do not have any severe illnesses that could affect my safety in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Continued access to sitravatinib and evaluation of safety and tolerability in patients deriving clinical benefit from a previous parent clinical trial

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sitravatinib

Trial Overview The study tests if Sitravatinib, on its own or combined with drugs like Ipilimumab, Nivolumab, Pembrolizumab, and Enfortumab Vedotin-Ejfv helps advanced solid tumors. It's for those who saw benefits in an earlier Mirati-sponsored trial.

How Is the Trial Designed?

Group I: Phase 2/3: Open label extension of parent study Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

Mirati Therapeutics Inc.

Lead Sponsor

Trials

73

Recruited

8,900+

Dr. Charles M. Baum

Mirati Therapeutics Inc.

Chief Executive Officer since 2023

MD, PhD

Dr. Joseph Leveque

Mirati Therapeutics Inc.

Chief Medical Officer since 2021

MD

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39513224/

Sitravatinib in patients with solid tumors selected by ... Conclusion: Sitravatinib had a manageable safety profile with modest signals of clinical activity in patients with molecularly selected solid tumors. Clinical ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/14796694.2024.2418285

Sitravatinib in patients with solid tumors selected by ... Overall, 68.9% had reduced tumor volume and most (61.5%) had a best objective response of stable disease. ORR was highest in patients with RET-rearranged non- ...

3. ohcare.com ohcare.com/sitravatinib-clinical-trial/

Drug Could Reduce Solid Tumor Growth Sitravatinib (MGCD516) is being tested in clinical trials to determine whether or not it is effective in reducing tumor cell growth as well as how the body ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11654803/

Sitravatinib in patients with solid tumors selected by molecular ... Overall, 68.9% had reduced tumor volume and most (61.5%) had a best objective response of stable disease. ORR was highest in patients with RET-rearranged non- ...

5. digitalcommons.library.tmc.edu digitalcommons.library.tmc.edu/cgi/viewcontent.cgi?article=4950&context=uthgsbs_docs

First-in-Human Phase 1/1b Study to Evaluate Sitravatinib in ... Overall objec- tive response rate was 11.8% in phase 1b, 13.2% in patients with non-small cell lung cancer (NSCLC) and 4.2% in patients with ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(20)34481-1/fulltext

Safety and Antitumor Activity of Sitravatinib in Combination ... We assessed the safety and antitumor activity of sitravatinib plus tislelizumab in patients with advanced solid tumors. Methods. This is an open-label, ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.4_suppl.281

Safety, tolerability, and preliminary antitumor activity of ... The combination of sitravatinib plus TIS showed preliminary antitumor activity, and a manageable safety profile, in pts with pre-treated, advanced GC/GEJC.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0923753420344811

Safety and Antitumor Activity of Sitravatinib in Combination ... Combination treatment with sitravatinib and tislelizumab was manageable and showed promising antitumor activity in patients with ovarian cancer.