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Differentiated Thyroid CancerPhase 2RAISENCT06458036

Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)

A Phase 2 study testing Selpercatinib Monotherapy and 131I Therapy in people with Differentiated Thyroid Cancer and Pediatric Cancer, run by Children's Hospital of Philadelphia at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. Read more about this study

Who is it for?
Ages 2 to 25 years
What is being tested?
Selpercatinib Monotherapy and 131I Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
5 sitesUnited States
Study dates
29 Jul 2024to 1 Nov 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 2-25 years, inclusive
  • Histologic diagnosis of a differentiated thyroid cancer, status post thyroidectomy and adequate local therapy (e.g., lymph node dissection as per standard of care) for metastatic disease in the neck in the opinion of the treating investigator
  • Anatomically evaluable disease on chest CT (Computed Tomography) meeting one of the following criteria (obtained within 90 days of enrollment):
  • multiple (> 10) noncalcified solid pulmonary nodules visible on CT and/or B. enlarging, discrete pulmonary nodules visible on CT of any number consistent with metastatic disease
  • Identification of an activating RET gene alteration (fusion or mutation). The RET alteration result should be generated from a laboratory with specific certifications (depending on country requirement) that clearly denotes the presence of a RET alteration without known kinase domain resistance mutation
  • Lansky/Karnofsky performance status >50%
Show all 19Show fewer
  • Adequate Organ Function
  • Bone Marrow Function:
  • Peripheral absolute neutrophil count (ANC) ≥1500/µL
  • Platelet count ≥ 100,000/µL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • Hemoglobin ≥ 9.0 g/dL at baseline (may receive Red Blood Cell transfusions).
  • Adequate Renal Function: Creatinine clearance or radioisotope Glomerular Filtration Rate (GFR) ≥ 70 mL/min/1.73 m2 or a maximum serum creatinine based on age/gender.
  • Adequate Liver Function
  • Bilirubin (sum of conjugated + unconjugated) < / = 1.5 x upper limit of normal (ULN) for age. Except participants with a documented history of Gilbert syndrome who must have a total bilirubin level of <3.0X ULN
  • Alanine aminotransferase (ALT) <2.5X ULN OR <5x ULN if the liver has tumor involvement. For the purpose of this study, the ULN for ALT is 45 U/L.
  • Serum albumin ≥ 2 g/dL
  • Patient must have normal serum potassium, calcium, and magnesium levels (may be receiving supplements)
  • Men with partners of childbearing potential or women of childbearing potential must agree to use a highly effective contraceptive method during treatment with study drug and for 6 months following the last dose of study drug. Selpercatinib could impair fertility in males and females. Advise women not to breastfeed during treatment with selpercatinib and for 1 week following the final dose
  • Women of childbearing potential must have a negative pregnancy test (serum or urine, consistent with local regulations) documented within 24 hours prior to treatment with study drug and at least monthly while on study treatment

Who cannot join

  • No prior systemic therapy for thyroid cancer, including RET inhibitors. Note: prior 131I is allowed.
  • Females who are pregnant or breastfeeding are excluded due to the potential risks of selpercatinib and radioactive iodine to the fetus/neonate.
  • Concurrent therapy: Patients currently receiving a strong CYP3A4 inducer or inhibitor are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided 14 days prior to treatment to the end of the study treatment.
  • Patients with clinically significant active cardiovascular disease, Torsades de pointes, or history of myocardial infarction within 6 months prior to planned start of study treatment or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 msec.
  • Have clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the drug.
  • Are taking a concomitant medication that is known to cause QTc prolongation.
  • Active hemorrhage or at significant risk for hemorrhage.
  • Uncontrolled hypertension (blood pressure greater than 140/90 in adults or greater than the 95% for height and gender in children). Use of anti-hypertensives to control blood pressure is permitted.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Meghan Donnelly, MPH contact

267-426-9343

23DT022@chop.edu

James Robinson contact

215-590-2053

robinsonj9@chop.edu

5 sites in 1 country

United States5 sites, 4 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Luz Castellanos, MD

    Recruiting

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

    Sara Helmig, MD

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Theodore Laetsch, MD, 267-425-2187, 23DT022@chop.edu

    Recruiting

  • The Unviersity of California, San Francisco (UCSF)

    San Francisco, California, 94143

    Arun Rangaswami, MD

    Not yet recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Terminated

Other trials in United States

About this study

Official title: Selpercatinib to Enhance RAI Avidity in Children, Adolescents, and Young Adults With Newly Diagnosed Differentiated Thyroid Cancers Harboring RET Fusions

Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.

Read the detailed description

This will be an open label, non-randomized study to evaluate the efficacy and safety of the combination of selpercatinib followed by 131I therapy for patients with RET fusion differentiated thyroid cancer. The primary Phase II objective will be to evaluate the pulmonary structural response rate at 18 months to the combination of selpercatinib given for 6-months followed by 131I therapy. This is exempt from Investigational New Drug requirements per the FDA.

Being tested
Selpercatinib Monotherapy, 131I Therapy
Keywords
Thyroid Cancer
Medical subject headings
Neoplasms, Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selpercatinib MonotherapyDrug

    Patients will receive selpercatinib monotherapy for 6 months at the FDA-approved dose.

  • 131I TherapyRadiation

    Patients will receive 131I therapy after 6 months of selpercatinib.

Study groups in NCT06458036
Study groupRoleWhat they receive
Experimental: Selpercatinib Monotherapy with 131I TherapyExperimentalPatients will receive selpercatinib monotherapy for 6 months at the FDA-approved dose. Patients will receive 131I therapy after 6 months of selpercatinib. Selpercatinib will be continued for 5 days after RAI therapy and then patients will enter a wait and see period off treatment. Patients who experience disease progression at any point while on selpercatinib will proceed to 131I therapy and discontinue selpercatinib.
Receives: Drug: Selpercatinib Monotherapy; Radiation: 131I Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with complete overall, pulmonary, structural, and biochemical response.

    Determine the overall, pulmonary, structural, and biochemical response rate to selpercatinib in patients with RET fusion differentiated thyroid cancer treated with 6 months of selpercatinib prior to 131I therapy

    Measured: 18 months

  2. Number of patients who survive without progression of disease after 5 years following protocol treatment.

    Determine the progression free survival to the combination of selpercatinib followed 6 months later 131I therapy from the initiation of selpercatinib therapy

    Measured: 5 years

  3. Proportion of all patients enrolled who show increased radioactive iodine avidity at 6 months following selpercatinib monotherapy.

    Determine the proportion of patients for whom oncogene-specific, targeted therapy increases tumor RAI-avidity.

    Measured: 6 months

  4. The incidence of adverse events and dose limiting toxicity with the combination of selpercatinib and 131I therapy, graded according to CTCAE v5.

    Determine the safety of the combination of selpercatinib given for 6-months followed by 131I therapy in patients with RET fusion differentiated thyroid cancer

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start29 Jul 2024
  3. Primary completion1 Nov 2030 (estimated)
  4. Study completion1 Nov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06458036
Sponsor's protocol ID
23-021524
Acronym
RAISE
Status last verified
Jul 2026
First submitted
10 Jun 2024
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selpercatinib Monotherapy and 131I Therapy in people with Differentiated Thyroid Cancer and Pediatric Cancer, run by Children's Hospital of Philadelphia at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Meghan Donnelly, MPH (267-426-9343, 23DT022@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with complete overall, pulmonary, structural, and biochemical response. (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06458036.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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