PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04544111
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Follicular Thyroid Cancer
  • Hurthle Cell Thyroid Neoplasia
  • Hurthle Cell Tumor
  • Papillary Thyroid Cancer
  • Poorly Differentiated Thyroid Gland Carcinoma
  • Thyroid Cancer
  • Thyroid Cancer, Follicular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trametinib — DRUG
    2mg by mouth daily \*If patient loses the ability to swallow while on study, trametinib may be provided as a powder in bottle for reconsititution. Trametinib, as a powder in bottle, will be mixed with sterile/purified water into an oral solution and administered PO or through enteral feeding tube
  • Dabrafenib — DRUG
    150 mg twice daily (OR at dose the patient previously tolerated)
  • PDR001 — DRUG
    400mg IV every 4 weeks

Study Details

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.

Key Dates

Start date
Sep 2, 2020
Status verified
Oct 2025
Primary completion
Sep 2, 2026
Completion
Sep 2, 2026

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A-BRAF WT tumors
    Cohort A (BRAF WT tumors): trametinib (T) 2mg by mouth daily plus PDR001 400mg IV every 4 weeks
  • Experimental: Cohort B-BRAF Mutant
    Cohort B (BRAF Mutant, resistant to previous BRAF inhibitors): dabrafenib (D) 150 mg twice daily (OR at dose the patient previously tolerated) plus PDR001 400mg IV every 4 weeks.

Primary Outcome Measure

Overall response rate [ Time Frame: 1 year ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (Limited protocol activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (Limited protocol activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065-
Memorial Sloan Kettering Nassau (Limited protocol activities)Rockville CentreNew York11553-

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited protocol activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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