ThyroidPhase 2NCT05059470
IMRT Followed by Pembrolizumab in the Adjuvant Setting in Anaplastic Cancer of the Thyroid (IMPAACT): Phase II Trial Adjuvant Pembrolizumab After IMRT in ATC
A Phase 2 study testing Pembrolizumab in people with Thyroid, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This is an open label, single center, phase 2 trial of adjuvant pembrolizumab after external beam radiation to the primary tumor in patients with stage IVB (disease localized to the neck) ATC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2022to 1 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female participants who are at least 18 years of age on the day of signing informed consent with Pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma will be enrolled in this study. Diagnosis may include consistent with or suggestive of terminology associated with: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present.
- Stage IVB disease (no convincing evidence of metastatic disease outside of the neck) who have unresectable disease are eligible in groups 1 or 2. Previous excisional biopsy is permitted.
- Stage IVB disease (no convincing evidence of metastatic disease outside of the neck) who have undergone complete resection of tumor (no convincing evidence of metastatic disease in the neck) are eligible in group 3
- Patient must have completed external beam radiation with or without concomitant cytotoxic chemotherapy to participate in groups 1 and 2. Those who have completed these treatment after surgical resection of primary tumor may participate in group 3.
- Patients may enroll only after completing radiation. Study drug may start from 2-6 weeks (+2 weeks) after radiation is completed and can only be started once radiation and chemotherapy-related toxicities are grade 2 or less (with the exception of alopecia). If a subject is consented but AEs are not grade 2 or less by 8 weeks after RT is completed, that subject is not eligible and should not start pembrolizumab.
- A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
Show all 12Show fewer
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days after the last dose of study treatment.
- A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 32 weeks (5 terminal half-lives for pembrolizumab plus an additional 90 days) from the last dose of study treatment and refrain from donating sperm during this period.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
- Adequate organ function as defined in the following table (Table 1). Specimens must be collected within 10 days prior to the start of study intervention.
Who cannot join
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose of pembrolizumab (see Appendix 3). A serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Show all 11Show fewer
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, not related to radiation.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA qualitative is detected) infection.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open label, single center, phase 2 trial of adjuvant pembrolizumab after external beam radiation to the primary tumor in patients with stage IVB (disease localized to the neck) ATC. This drug trial will estimate the median progression-free survival (PFS) (from the start of adjuvant pembrolizumab until locoregional progression, development of distant metastatic disease, or death) in stage IVB ATC patients with gross disease, treated with external beam radiation (+/- concomitant chemotherapy) followed by adjuvant pembrolizumab. Patients will be patients enrolled from cohort 1 and 2 (cohort 1: ≥51 Gy; cohort 2: ≤50 Gy).
Read the detailed description
Primary Objective:
-To estimate the median progression-free survival (PFS) (from the start of adjuvant pembrolizumab until locoregional progression, development of distant metastatic disease, or death) in stage IVB ATC patients with gross disease, treated with external beam radiation (+/- concomitant chemotherapy) followed by adjuvant pembrolizumab. Patients will be patients enrolled from cohort 1 and 2 (cohort 1: ≥51 Gy; cohort 2: ≤50 Gy).
Secondary Objective:
-To estimate median overall survival in stage IVB ATC patients treated with external beam radiation (+/- concurrent chemotherapy) followed by adjuvant pembrolizumab. Patients will be stratified by dose of external beam radiation.
Exploratory Objective:
-To estimate the median disease-free survival (DFS) in patients with stage IVB ATC treated with surgery/external beam radiation/concomitant chemotherapy followed by adjuvant pembrolizumab (cohort 3).
- Conditions
- Thyroid
- Being tested
- Pembrolizumab
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab | Experimental | The infusions are given every 6 weeks Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-free Survival (PFS) in Stage IVB ATC Patients With Gross Disease Treated With External Beam Radiation Followed by Adjuvant Pembrolizumab
To estimate the median progression-free survival (PFS) (from the start of adjuvant pembrolizumab until locoregional progression, development of distant metastatic disease, or death) in stage IVB ATC patients with gross disease, treated with external beam radiation (+/- concomitant chemotherapy) followed by adjuvant pembrolizumab. Patients will be patients enrolled from cohort 1 and 2 cohort 1: >51 Gy; cohort 2: <50 Gy).
Measured: From the start of adjuvant pembrolizumab until disease progression or death
Median Overall Survival (OS) in Stage IVB ATC Patients Treated With External Beam Radiation Followed by Adjuvant Pembrolizumab
To estimate median overall survival in stage IVB ATC patients treated with external beam radiation (+/- concurrent chemotherapy) followed by adjuvant pembrolizumab. Patients will be stratified by dose of external beam radiation.
Measured: From the start of adjuvant pembrolizumab until disease progression or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start11 Feb 2022
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Why it stopped: \<75% participant accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ThyroidStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Cabanillas, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059470
- Sponsor's protocol ID
- 2021-0704
- Other IDs
- NCI-2021-10669
- Status last verified
- Mar 2026
- First submitted
- 15 Sep 2021
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMRT Followed by Pembrolizumab in the Adjuvant Setting in Anaplastic Cancer of the Thyroid (IMPAACT): Phase II Trial Adjuvant Pembrolizumab After IMRT in ATC
- ClinicalTrials.gov ID
- NCT05059470
- Acronym / sponsor ID
- 2021-0704
- Conditions
- Thyroid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75% participant accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, single center, phase 2 trial of adjuvant pembrolizumab after external beam radiation to the primary tumor in patients with stage IVB (disease localized to the neck) ATC. This drug trial will estimate the median progression-free survival (PFS) (from the start of adjuvant pembrolizumab until locoregional progression, development of distant metastatic disease, or death) in stage IVB ATC patients with gross disease, treated with external beam radiation (+/- concomitant chemotherapy) followed by adjuvant pembrolizumab. Patients will be patients enrolled from cohort 1 and 2 (cohort 1: ≥51 Gy; cohort 2: ≤50 Gy).
Detailed description
Primary Objective:
-To estimate the median progression-free survival (PFS) (from the start of adjuvant pembrolizumab until locoregional progression, development of distant metastatic disease, or death) in stage IVB ATC patients with gross disease, treated with external beam radiation (+/- concomitant chemotherapy) followed by adjuvant pembrolizumab. Patients will be patients enrolled from cohort 1 and 2 (cohort 1: ≥51 Gy; cohort 2: ≤50 Gy).
Secondary Objective:
-To estimate median overall survival in stage IVB ATC patients treated with external beam radiation (+/- concurrent chemotherapy) followed by adjuvant pembrolizumab. Patients will be stratified by dose of external beam radiation.
Exploratory Objective:
-To estimate the median disease-free survival (DFS) in patients with stage IVB ATC treated with surgery/external beam radiation/concomitant chemotherapy followed by adjuvant pembrolizumab (cohort 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab | Experimental | Drug: PembrolizumabThe infusions are given every 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male/female participants who are at least 18 years of age on the day of signing informed consent with Pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma will be enrolled in this study. Diagnosis may include consistent with or suggestive of terminology associated with: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present.
- Stage IVB disease (no convincing evidence of metastatic disease outside of the neck) who have unresectable disease are eligible in groups 1 or 2. Previous excisional biopsy is permitted.
- Stage IVB disease (no convincing evidence of metastatic disease outside of the neck) who have undergone complete resection of tumor (no convincing evidence of metastatic disease in the neck) are eligible in group 3
- Patient must have completed external beam radiation with or without concomitant cytotoxic chemotherapy to participate in groups 1 and 2. Those who have completed these treatment after surgical resection of primary tumor may participate in group 3.
- Patients may enroll only after completing radiation. Study drug may start from 2-6 weeks (+2 weeks) after radiation is completed and can only be started once radiation and chemotherapy-related toxicities are grade 2 or less (with the exception of alopecia). If a subject is consented but AEs are not grade 2 or less by 8 weeks after RT is completed, that subject is not eligible and should not start pembrolizumab.
Key exclusion criteria (11 listed)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose of pembrolizumab (see Appendix 3). A serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabGiven by IV | Drug | Pembrolizumab |
Primary outcome
Median Progression-free Survival (PFS) in Stage IVB ATC Patients With Gross Disease Treated With External Beam Radiation Followed by Adjuvant Pembrolizumab
Time frame: From the start of adjuvant pembrolizumab until disease progression or death
To estimate the median progression-free survival (PFS) (from the start of adjuvant pembrolizumab until locoregional progression, development of distant metastatic disease, or death) in stage IVB ATC patients with gross disease, treated with external beam radiation (+/- concomitant chemotherapy) followed by adjuvant pembrolizumab. Patients will be patients enrolled from cohort 1 and 2 cohort 1: >51 Gy; cohort 2: <50 Gy).
Median Overall Survival (OS) in Stage IVB ATC Patients Treated With External Beam Radiation Followed by Adjuvant Pembrolizumab
Time frame: From the start of adjuvant pembrolizumab until disease progression or death
To estimate median overall survival in stage IVB ATC patients treated with external beam radiation (+/- concurrent chemotherapy) followed by adjuvant pembrolizumab. Patients will be stratified by dose of external beam radiation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- M D Anderson Cancer CenterLink provided by the sponsor.
Related trials for Thyroid
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Cabanillas, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Thyroid, run by M.D. Anderson Cancer Center at 1 site 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 12 inclusion and 11 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: stopped early, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Progression-free Survival (PFS) in Stage IVB ATC Patients With Gross Disease Treated With External Beam Radiation Followed by Adjuvant Pembrolizumab (time frame: From the start of adjuvant pembrolizumab until disease progression or death). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.