Axitinib for Alveolar Soft Part Sarcoma

Phase 2

Waitlist Available

Led By Jonathan C Trent, MD

Research Sponsored by Jonathan Trent, MD, PhD

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using Axitinib and Pembrolizumab together can slow down tumor growth in patients. Axitinib cuts off the tumor's food supply, and Pembrolizumab helps the immune system fight the cancer. The combination may be easier to manage due to the flexible dosing of Axitinib.

Eligible Conditions

Alveolar Soft Part Sarcoma
Soft Tissue Sarcoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Evaluable Participants Achieving Progression-Free Survival (PFS) at 3 Months

Secondary study objectives

Number of Participants Experiencing Serious Adverse Events (SAEs), Dose-Limiting Toxicities, and Grade 3 or Higher Treatment-Emergent Adverse Events

Overall Survival (OS)

Percentage of Evaluable Participants Achieving Clinical Benefit Response (CBR)

+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

Group I: Axitinib Plus Pembrolizumab GroupExperimental Treatment2 Interventions

Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.

Group II: Axitinib Plus Pembrolizumab Expansion CohortExperimental Treatment2 Interventions

Expansion cohort for up to 10 additional patients with alveolar soft part sarcoma. Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axitinib

2020

Completed Phase 2

~3050

Pembrolizumab

2017

Completed Phase 3

~3150