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Checkpoint Inhibitor

Immunotherapy + Chemotherapy for Soft Tissue Sarcoma

Phase 2

Waitlist Available

Led By A P Chen

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and c2d22

Awards & highlights

Study Summary

This trial tests 2 combinations of drugs to fight advanced soft tissue sarcoma: immunotherapy and chemotherapy.

Who is the study for?

Adults (18+) with advanced soft tissue sarcoma, including specific types like undifferentiated pleomorphic sarcoma and liposarcoma. Participants must have measurable disease, acceptable organ function, controlled blood pressure without multiple medications, and no prior treatment with certain inhibitors or the study drugs. They should not be pregnant or breastfeeding and must agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing if adding Cabozantinib to immunotherapy drugs Ipilimumab and Nivolumab improves outcomes in patients with advanced soft tissue sarcomas. It's a phase II trial where some participants will receive all three drugs while others will only get the immunotherapies.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, high blood pressure due to Cabozantinib which can also cause fatigue, hand-foot syndrome (redness and pain on palms/soles), mouth sores, diarrhea, liver issues from Ipilimumab/Nivolumab as well as potential infusion-related symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and c2d22

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and c2d22

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and c2d22 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Number of tumor-infiltrating CD8+ T cells

Objective response rate

Other outcome measures

Genetic aberrations and/or tumor mutational burden

Overall response

T cell receptor signaling in tumor-infiltrating T cells

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (cabozantinib, nivolumab, ipilimumab)Experimental Treatment7 Interventions

Patients receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity. Patients receive nivolumab IV and ipilimumab IV on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity for 4 cycles. Patients then receive nivolumab IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans, tumor biopsies, and collection of blood throughout the trial.

Group II: Arm A (nivolumab, ipilimumab)Active Control6 Interventions

Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity for 4 cycles. Patients then receive nivolumab IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans, tumor biopsies, and collection of blood throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Ipilimumab

2014

Completed Phase 3

~2620

Nivolumab

2014

Completed Phase 3

~4750

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1730

Cabozantinib

2020

Completed Phase 2

~1080

Computed Tomography

2017

Completed Phase 2

~2720

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,206 Total Patients Enrolled

28 Trials studying Liposarcoma

2,077 Patients Enrolled for Liposarcoma

A P ChenPrincipal InvestigatorNational Cancer Institute LAO

7 Previous Clinical Trials

524 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How perilous is the combination of cabozantinib, nivolumab and ipilimumab for participants?

"Our team's assessment of the safety of Arm B (cabozantinib, nivolumab, ipilimumab) is a 2. Since this trial has only reached Phase 2 status there is limited data available to ascertain efficacy but some evidence in regards to its security."

Answered by AI

Are individuals currently being recruited for this scientific experiment?

"Affirmative. According to clinicaltrials.gov, the trial which was first posted on June 25th 2024 is still actively recruiting patients; 66 participants are needed from 2 sites."

Answered by AI

What is the aggregate quantity of subjects taking part in this experiment?

"Indeed, the clinicaltrials.gov database confirms that this medical experiment is actively recruiting applicants. The trial was initiated on June 25th 2024 and recently updated on October 13th 2023. 66 new participants need to be enrolled between 2 facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma

2023. "Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05836571.