Vemurafenib + Copanlisib for Thyroid Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byAlan L Ho, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop a new drug treatment to reverse tumor resistance to radioiodine in BRAF mutant tumors so that radioiodine can be given to shrink tumors. This study is also being done to find out the highest doses of copanlisib and vemurafenib that, when given in combination, do not cause serious side effects, and whether the study treatment will make radioiodine therapy work better in patients with BRAF-mutant thyroid cancers.

Research Team

Alan L Ho, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with thyroid cancer of follicular origin (like papillary or poorly differentiated subtypes) that have a BRAF V600 mutation and haven't had recent treatment. They must be able to take pills, agree to biopsies, have RAIR disease, measurable tumor growth, good performance status, and meet lab value criteria. Pregnant individuals, those with certain medical conditions or on prohibited meds can't join.

Inclusion Criteria

I can swallow pills without any major stomach or intestine problems.

I have tissue samples from my cancer available for study.

I am mostly able to care for myself and carry out daily activities.

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Exclusion Criteria

Substance abuse or medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

I am not using highly effective birth control methods.

I take medication for seizures.

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Treatment Details

Interventions

Copanlisib (Kinase Inhibitor)
Vemurafenib (Kinase Inhibitor)

Trial OverviewThe study tests combining two drugs—Vemurafenib and Copanlisib—to see if they can make radioiodine therapy more effective in shrinking tumors resistant to it in patients with BRAF-mutant thyroid cancers. It also aims to find the highest safe doses of these drugs when used together.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Participants with thyroid cancerExperimental Treatment3 Interventions

Eligible participants will have a diagnosis of BRAF mutant RAIR thyroid cancer