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PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started2020-09-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 2, 2026 → Sep 2, 2027
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-09-18
critical
Primary completion pushed: 2026-09-02 → 2027-09-02
Completion pushed: 2026-09-02 → 2027-09-02
2025-10-06
minor
Study Status v12
Primary completion date2025-09-02→2026-09-02
Completion date2025-09-02→2026-09-02
2025-05-13
minor
3 amendments v9-v11
3 re-verifications since 2024-09-23, no change to tracked fields
2023-09-21
minor
Study Status v8
Primary completion date2023-09-02→2025-09-02
Completion date2023-09-02→2025-09-02
2023-05-11
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 30→confirmed 19
Study sitesdetails revised at 7 of 7 sites
Show 6 earlier versions
2023-01-19
minor
Study Status, Contacts/Locations v6
Study sites7 entries, revised
MemoralMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities) MemoralMemorial Sloan Kettering Monmouth (Limited protocol activities) MemoralMemorial Sloan Kettering Westchester (Limited protocol activities)
2022-04-29
minor
Study Status, Arms and Interventions v5
Primary completion date2022-09-02→2023-09-02
Completion date2022-09-02→2023-09-02
2021-12-07
minor
2 amendments v3-v4
2 re-verifications since 2021-10-04, no change to tracked fields
2021-01-07
minor
Study Status, Eligibility v2
Eligibility criteria+757 characters
[...] uding BRAF translocations, may be included in this cohort). Cohort A Only: Evidence of progressive disease (e.g. presence of new or growing lesion(s) on radiologic imaging and/or new or worsening tumor-related symptoms) within 14 months of study enrollment Cohort B Only: Confirmation in a CLIA certified laboratory t [...] nitiation of therapy on this protocol (an exception to this isare patients on prior BRAF targeted therapydabrafenib who will be enrolling into Cohort B). Dabrafenib may be continued prior to and through trial enrollment into the start of the study therapy when PDR001 will be added t [...] [...]
2020-11-13
minor
Study Status, Contacts/Locations v1
Study sites1→7
2020-09-03
minor
Original filing
The purpose of this study is to find out whether a drug called PDR001, combined with either trametinib or dabrafenib, is a safe and effective treatment for thyroid cancer.
Trial Details
NCT Number NCT04544111
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Thyroid Cancer, Thyroid Cancer, Follicular, Papillary Thyroid Cancer, Follicular Thyroid Cancer, Hurthle Cell Tumor, Poorly Differentiated Thyroid Gland Carcinoma, Hurthle Cell Thyroid Neoplasia
Enrollment 19 participants
Start Date 2020-09-02
Primary Completion 2027-09-02 (estimated)
Study Completion 2027-09-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-17