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Checkpoint Inhibitor

Immunotherapy + Chemotherapy for Soft Tissue Sarcoma

Phase 2

Recruiting

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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Number of tumor-infiltrating CD8+ T cells

Objective response rate

Other study objectives

Genetic aberrations and/or tumor mutational burden

Overall response

T cell receptor signaling in tumor-infiltrating T cells

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Ipilimumab

2015

Completed Phase 3

~3070

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160