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Tyrosine Kinase Inhibitor

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
alveolar soft part sarcoma
clear cell sarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will test if the drugs Axitinib and Pembrolizumab can work together to slow tumor growth, as well as to observe any side effects of the combination treatment.

Eligible Conditions
  • Alveolar Soft Part Sarcoma
  • Soft Tissue Sarcoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a type of cancer called alveolar soft part sarcoma.
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You have a type of cancer called clear cell sarcoma.
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You have rhabdomyosarcoma.
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You have chordoma.
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You have a type of cancer called synovial sarcoma.
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You have leiomyosarcoma.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Evaluable Participants Achieving Progression-Free Survival (PFS) at 3 Months
Secondary outcome measures
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

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 2
~1950

Find a Location

Who is running the clinical trial?

Jonathan Trent, MD, PhDLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,867 Previous Clinical Trials
5,051,750 Total Patients Enrolled
PfizerIndustry Sponsor
4,560 Previous Clinical Trials
10,907,151 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 many people have signed up for this research project?

"This particular study is not currently enrolling patients; however, it was updated as recently as October 20th, 2022. There are 461 other clinical trials for sarcoma and 1043 for Pembrolizumab that are actively seeking participants."

Answered by AI

What is the primary purpose of this experiment?

"The sponsor of this clinical trial, Merck Sharp & Dohme LLC reports that the primary outcome being measured over a 3 month period is percentage of patients who achieve progression-free survival (PFS) at 3 months. Additionally, this study will measure secondary outcomes such as percentage of patients who respond to treatment with complete response (CR), partial response (PR), or stable disease (SD) using RECIST 1.1., overall survival(OS), and number of participants experiencing serious adverse events (SAEs), dose-limiting toxicities, and grade 3 or higher treatment emergent adverse events . Treatment emergent adverse events are those"

Answered by AI

Has the Food and Drug Administration cleared Pembrolizumab for general use?

"While Phase 2 trials don't have data supporting efficacy, there is some evidence that Pembrolizumab is safe. Consequently, our estimation at Power ranks it as a 2."

Answered by AI

What are the top conditions that Pembrolizumab helps to treat?

"Pembrolizumab is an immunotherapy drug that can be used to treat patients with malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

Are participants still being sought for this research?

"Unfortunately, this trial is not currently looking for new patients. Although, it's worth noting that the original posting date was April 19th, 2016 and the latest update occurred on October 20th, 2022. There are 461 other trials actively enrolling sarcoma patients and 1043 Pembrolizumab trials with open participation at this time."

Answered by AI

What is the medical research surrounding Pembrolizumab?

"As of now, there are 1,043 active clinical trials for Pembrolizumab with 125 in Phase 3. Most of the Pembrolizumab trials are taking place in Houston, Texas; however, there are a total of 36997 locations running these sorts of tests."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~4 spots leftby Mar 2025