Trial Outcomes & Findings for RAI Plus Immunotherapy for Recurrent/Metastatic Thyroid Cancers (NCT NCT03215095)
NCT ID: NCT03215095
Last Updated: 2025-07-17
Results Overview
Grading of DLTs will follow the guidelines provided in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
EARLY_PHASE1
Target enrollment
11 participants
Primary outcome timeframe
6 weeks beginning from the first durvalumab
Results posted on
2025-07-17
Participant Flow
Participant milestones
| Measure |
Radioiodine (RAI) in Combination With Durvalumab (Medi4736)
Enrolled patients will be treated with durvalumab 1500 mg IV every 4 weeks. In Cycle 1/Week 3, Thyrogen 0.9 mg IM will be administered on two consecutive calendar days followed by 100 mCi (+/- 10 mCi) of RAI the next calendar day. Durvalumab will be continued every 4 weeks.
Durvalumab (Medi4736): durvalumab 1500 mg IV every 4 weeks
Radioiodine (RAI): 100 mCi (+/- 10 mCi) of 131I will be administered a day after Thyrogen injections have been administered for two consecutive calendar days.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RAI Plus Immunotherapy for Recurrent/Metastatic Thyroid Cancers
Baseline characteristics by cohort
| Measure |
Radioiodine (RAI) in Combination With Durvalumab (Medi4736)
n=11 Participants
Enrolled patients will be treated with durvalumab 1500 mg IV every 4 weeks. In Cycle 1/Week 3, Thyrogen 0.9 mg IM will be administered on two consecutive calendar days followed by 100 mCi (+/- 10 mCi) of RAI the next calendar day. Durvalumab will be continued every 4 weeks.
Durvalumab (Medi4736): durvalumab 1500 mg IV every 4 weeks
Radioiodine (RAI): 100 mCi (+/- 10 mCi) of 131I will be administered a day after Thyrogen injections have been administered for two consecutive calendar days.
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks beginning from the first durvalumabGrading of DLTs will follow the guidelines provided in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Radioiodine (RAI) in Combination With Durvalumab (Medi4736)
n=11 Participants
Enrolled patients will be treated with durvalumab 1500 mg IV every 4 weeks. In Cycle 1/Week 3, Thyrogen 0.9 mg IM will be administered on two consecutive calendar days followed by 100 mCi (+/- 10 mCi) of RAI the next calendar day. Durvalumab will be continued every 4 weeks.
Durvalumab (Medi4736): durvalumab 1500 mg IV every 4 weeks
Radioiodine (RAI): 100 mCi (+/- 10 mCi) of 131I will be administered a day after Thyrogen injections have been administered for two consecutive calendar days.
|
|---|---|
|
Number of Patients With Dose-Limiting Toxicity (DLTs)
Participants with DLTs
|
0 Participants
|
|
Number of Patients With Dose-Limiting Toxicity (DLTs)
Participants with no DLTs
|
11 Participants
|
SECONDARY outcome
Timeframe: 2 yearsResponse and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Outcome measures
| Measure |
Radioiodine (RAI) in Combination With Durvalumab (Medi4736)
n=11 Participants
Enrolled patients will be treated with durvalumab 1500 mg IV every 4 weeks. In Cycle 1/Week 3, Thyrogen 0.9 mg IM will be administered on two consecutive calendar days followed by 100 mCi (+/- 10 mCi) of RAI the next calendar day. Durvalumab will be continued every 4 weeks.
Durvalumab (Medi4736): durvalumab 1500 mg IV every 4 weeks
Radioiodine (RAI): 100 mCi (+/- 10 mCi) of 131I will be administered a day after Thyrogen injections have been administered for two consecutive calendar days.
|
|---|---|
|
Best Overall Response
Partial Response
|
2 Participants
|
|
Best Overall Response
Stable Disease
|
7 Participants
|
|
Best Overall Response
Progressive Disease
|
2 Participants
|
Adverse Events
Radioiodine (RAI) in Combination With Durvalumab (Medi4736)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Radioiodine (RAI) in Combination With Durvalumab (Medi4736)
n=11 participants at risk
Enrolled patients will be treated with durvalumab 1500 mg IV every 4 weeks. In Cycle 1/Week 3, Thyrogen 0.9 mg IM will be administered on two consecutive calendar days followed by 100 mCi (+/- 10 mCi) of RAI the next calendar day. Durvalumab will be continued every 4 weeks.
Durvalumab (Medi4736): durvalumab 1500 mg IV every 4 weeks
Radioiodine (RAI): 100 mCi (+/- 10 mCi) of 131I will be administered a day after Thyrogen injections have been administered for two consecutive calendar days.
|
|---|---|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.1%
1/11 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • 2 years
|
|
Investigations
Weight loss
|
9.1%
1/11 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
1/11 • 2 years
|
|
General disorders
Fatigue
|
27.3%
3/11 • 2 years
|
|
Nervous system disorders
Paresthesia
|
9.1%
1/11 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
9.1%
1/11 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.1%
1/11 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
2/11 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • 2 years
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
9.1%
1/11 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • 2 years
|
|
Investigations
Neutrophil Count Decrease
|
9.1%
1/11 • 2 years
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • 2 years
|
|
Investigations
Platelet Count Decrease
|
9.1%
1/11 • 2 years
|
Additional Information
Dr. Alan Ho, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place