Selpercatinib for Solid Tumors and Lymphomas

Recruiting at182 trial locations

Overseen by Andrea T Franson

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II pediatric MATCH treatment trial studies how well selpercatinib works in treating patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), lymphomas, or histiocytic disorders that have activating RET gene alterations. Selpercatinib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway (called the RET pathway) and may reduce tumor size.

Research Team

Andrea T Franson

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for children and young adults up to 21 years old with advanced solid tumors, lymphomas, or histiocytic disorders that have specific RET gene changes. They must be in good physical condition with adequate organ function and not have been treated with selpercatinib before. Pregnant or breastfeeding individuals, those who've had major surgery recently, or are on certain medications affecting the immune system can't participate.

Inclusion Criteria

I have recovered from side effects of my previous cancer treatments.

I was assigned a treatment in the APEC1621SC study due to a specific mutation.

You have enough infection-fighting white blood cells in your body.

Exclusion Criteria

I do not have any infections that are currently uncontrolled.

I have been on a stable or decreasing dose of corticosteroids for at least 7 days.

I am not taking drugs that strongly affect liver enzyme CYP3A4.

Treatment Details

Interventions

• Selpercatinib (Tyrosine Kinase Inhibitor)

Trial Overview The trial is testing selpercatinib's effectiveness on patients whose cancer has spread and have alterations in the RET gene—a key driver of tumor growth. It involves imaging tests like CT scans, MRIs, PET scans, and X-rays to monitor response to treatment.

Participant Groups

Group I: Treatment (selpercatinib) Experimental Treatment 6 Interventions

Patients receive selpercatinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients may also undergo PET, CT, MRI, PET/CT, PET/MRI, and/or CT/MRI, scintigraphy, and x-ray imaging throughout the trial.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Children's Oncology Group

Collaborator

Trials

467

Recruited

241,000+

Dr. Doug Hawkins

Children's Oncology Group

Chief Executive Officer since 2020

MD from University of Washington School of Medicine

Dr. Leo Mascarenhas

Children's Oncology Group

Chief Medical Officer since 2024

MD, MS from Cedars-Sinai Guerin Children’s