Trial · NCT03246958
Nivolumab Plus Ipilimumab in Thyroid Cancer
NCT03246958, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2024-05-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nivolumab Plus Ipilimumab in Thyroid Cancer. Trials, record NCT03246958. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03246958
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab Plus Ipilimumab in Thyroid Cancer
- NCT number
- NCT03246958
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Thyroid Cancer
- Interventions
- Nivolumab, Ipilimumab
- First posted
- 2017-08-11
- Last updated
- 2025-06-19
- Results first posted
- 2024-05-21
- Limitations and caveats
- Limited number of patients accrued into ATC and MTC cohort.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate | Median (range) treatment duration (days) of 163.0 (21.0-734.0) for DTC cohort, for MTC cohort was 58.0 (30.0-252.0), and for ATC cohort 135.5 (10.0-735.0). | Best overall response rate is defined as the percentage of participants who achieved Complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Median Progression Free Survival | Median (range) follow-up (months) for DTC cohort was 24.0 (1.84 - 24.7), for MTC cohort was 24.0 (23.0-24.2), and for ATC cohort was 22.2 (0.46 - 26.1). | Progression-Free Survival (PFS) based on Kaplan-Meier methodology is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated. |
| Secondary | Overall Survival at 2 Years (OS2) | Median (range) follow-up (months) for DTC cohort was 24.0 (1.84 - 24.7), for MTC cohort was 24.0 (23.0-24.2), and for ATC cohort was 22.2 (0.46 - 26.1). | Overall Survival is the percent probability estimate at 2 years based on Kaplan-Meier methodology. OS is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. |
| Secondary | Treatment-Related Adverse Events Rate | AEs were assessed every two weeks on treatment and within 30 days after the last dose. Median (range) treatment duration (days) of 163.0 (21.0-734.0) for DTC cohort, for MTC cohort was 58.0 (30.0-252.0), and for ATC cohort 135.5 (10.0-735.0). | Treatment-related adverse events rate was defined as the proportion of participants who experienced an adverse event with treatment attribution of possible, probable or definite, including all grades based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) as reported on case report forms. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response Rate | Median (range) treatment duration (days) of 163.0 (21.0-734.0) for DTC cohort, for MTC cohort was 58.0 (30.0-252.0), and for ATC cohort 135.5 (10.0-735.0). | It was pre-specified in the Study Protocol to report data by disease cohort irrespective of assigned treatment sequence. | percentage of participants | NUMBER |
| SECONDARY | Median Progression Free Survival | Median (range) follow-up (months) for DTC cohort was 24.0 (1.84 - 24.7), for MTC cohort was 24.0 (23.0-24.2), and for ATC cohort was 22.2 (0.46 - 26.1). | It was pre-specified in the Study Protocol to report data by disease cohort irrespective of assigned treatment sequence. | Months | MEDIAN |
| SECONDARY | Overall Survival at 2 Years (OS2) | Median (range) follow-up (months) for DTC cohort was 24.0 (1.84 - 24.7), for MTC cohort was 24.0 (23.0-24.2), and for ATC cohort was 22.2 (0.46 - 26.1). | It was pre-specified in the Study Protocol to report data by disease cohort irrespective of assigned treatment sequence. | Percent Probability | NUMBER |
| SECONDARY | Treatment-Related Adverse Events Rate | AEs were assessed every two weeks on treatment and within 30 days after the last dose. Median (range) treatment duration (days) of 163.0 (21.0-734.0) for DTC cohort, for MTC cohort was 58.0 (30.0-252.0), and for ATC cohort 135.5 (10.0-735.0). | It was pre-specified in the Study Protocol to report data by disease cohort irrespective of assigned treatment sequence. | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rate | Differentiated Thyroid Cancer (Primary Cohort) | 9.4 | 95% Confidence Interval 2.8 to 28.5 | percentage of participants | |
| Best Overall Response Rate | Medullary Thyroid Cancer (Exploratory Cohort) | 0 | 95% Confidence Interval 0 to 41 | percentage of participants | |
| Best Overall Response Rate | Anaplastic Thyroid Cancer (Exploratory Cohort) | 30 | 95% Confidence Interval 6.7 to 65.2 | percentage of participants | |
| Median Progression Free Survival | Differentiated Thyroid Cancer (Primary Cohort) | 7.11 | 95% Confidence Interval 2.07 to 17.02 | Months | |
| Median Progression Free Survival | Medullary Thyroid Cancer (Exploratory Cohort) | 2.14 | 95% Confidence Interval 0.92 to 3.98 | Months | |
| Median Progression Free Survival | Anaplastic Thyroid Cancer (Exploratory Cohort) | 4.29 | 95% Confidence Interval 0.46 to NA | Months | |
| Overall Survival at 2 Years (OS2) | Differentiated Thyroid Cancer (Primary Cohort) | 77.2 | 95% Confidence Interval 58.1 to 88.5 | Percent Probability | |
| Overall Survival at 2 Years (OS2) | Medullary Thyroid Cancer (Exploratory Cohort) | 85.7 | 95% Confidence Interval 33.4 to 97.9 | Percent Probability | |
| Overall Survival at 2 Years (OS2) | Anaplastic Thyroid Cancer (Exploratory Cohort) | 55.6 | 95% Confidence Interval 20.4 to 80.5 | Percent Probability | |
| Treatment-Related Adverse Events Rate | Differentiated Thyroid Cancer (Primary Cohort) | 0.81 | 95% Confidence Interval 0.64 to 0.93 | proportion of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DTC - Nivolumab Alone for Two Weeks | 17 | |
| Overall Study | STARTED | DTC - Ipilimumab Alone for Two Weeks | 18 | |
| Overall Study | STARTED | MTC - Nivolumab Alone for Two Week | 3 | |
| Overall Study | STARTED | MTC - Ipilimumab Alone for Two Weeks | 4 | |
| Overall Study | STARTED | ATC - Nivolumab Alone for Two Week | 2 | |
| Overall Study | STARTED | ATC - Ipilimumab Alone for Two Week | 4 | |
| Overall Study | STARTED | ATC - Ipilimumab + Nivolumab | 4 | |
| Overall Study | Analyzable | DTC - Nivolumab Alone for Two Weeks | 16 | |
| Overall Study | Analyzable | DTC - Ipilimumab Alone for Two Weeks | 16 | |
| Overall Study | Analyzable | MTC - Nivolumab Alone for Two Week | 3 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events1,155
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | DTC - Nivolumab Alone for Two Weeks | 2 | 16 | |
| other | Anemia | Blood and lymphatic system disorders | DTC - Ipilimumab Alone for Two Weeks | 2 | 16 | |
| other | Anemia | Blood and lymphatic system disorders | MTC - Nivolumab Alone for Two Week | 0 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | MTC - Ipilimumab Alone for Two Weeks | 0 | 4 | |
| other | Anemia | Blood and lymphatic system disorders | ATC - Nivolumab Alone for Two Week | 1 | 2 | |
| other | Anemia | Blood and lymphatic system disorders | ATC - Ipilimumab Alone for Two Week | 0 | 4 | |
| other | Anemia | Blood and lymphatic system disorders | ATC - Ipilimumab + Nivolumab | 0 | 4 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | DTC - Nivolumab Alone for Two Weeks | 1 | 16 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | DTC - Ipilimumab Alone for Two Weeks | 1 | 16 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | MTC - Nivolumab Alone for Two Week | 0 | 3 |
1 to 10 of 1,155Source ClinicalTrials.gov
See all 1,155 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DTC - Nivolumab Alone for Two Weeks | 5 | 16 |
| Total, all-cause mortality | DTC - Ipilimumab Alone for Two Weeks | 5 | 16 |
| Total, all-cause mortality | MTC - Nivolumab Alone for Two Week | 1 | 3 |
| Total, all-cause mortality | MTC - Ipilimumab Alone for Two Weeks | 0 | 4 |
| Total, all-cause mortality | ATC - Nivolumab Alone for Two Week | 1 | 2 |
| Total, all-cause mortality | ATC - Ipilimumab Alone for Two Week | 2 | 4 |
| Total, all-cause mortality | ATC - Ipilimumab + Nivolumab | 1 | 4 |
| Total, other adverse events | DTC - Nivolumab Alone for Two Weeks | 16 | 16 |
| Total, other adverse events | DTC - Ipilimumab Alone for Two Weeks | 16 | 16 |
| Total, other adverse events | MTC - Nivolumab Alone for Two Week | 3 | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39446365 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03246958
GET https://conductscience.org/api/trials/v1/NCT03246958/flow?page=2