Trial · NCT03816332
Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
NCT03816332, Phase 1, Active not recruiting, National Cancer Institute (NCI); results first posted 2023-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers. Trials, record NCT03816332. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03816332
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
- NCT number
- NCT03816332
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Metastatic Basal Cell Carcinoma, Metastatic Melanoma, Metastatic Merkel Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Unresectable Basal Cell Carcinoma, Unresectable Melanoma, Unresectable Merkel Cell Carcinoma
- Interventions
- Ipilimumab, Nivolumab, Prednisone, Tacrolimus
- First posted
- 2019-01-25
- Last updated
- 2026-10-14
- Results first posted
- 2023-06-27
- Limitations and caveats
- The second treatment period where participants received ipilimumab, nivolumab, tacrolimus, and prednisone was optional.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone | At 16 weeks | Percentage of kidney transplant recipients who experienced complete response (CR), partial response (PR) or stable disease (SD) without allograft loss. |
| Secondary | Objective Response (CR or PR) Rate (ORR) After Receiving Nivolumab, Tacrolimus, and Prednisone | Up to 4 months | Number (and percentage) of patients with a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria after receiving at least one dose of nivolumab. |
| Secondary | Rate of Allograft Loss After Receiving Nivolumab, Tacrolimus, and Prednisone | Up to 4 months | Number of subjects who experienced allograft loss after receiving at least one dose of nivolumab. |
| Secondary | Duration of Progression-free Survival After Receiving Nivolumab, Tacrolimus, and Prednisone | Up to 4 months | From the first dose of nivolumab to the date of the first documented tumor progression or death due to any cause, whichever occurs first. |
| Secondary | Duration of Overall Survival After Receiving Nivolumab, Tacrolimus, and Prednisone | Up to 3 years | The time from the participant's first dose of nivolumab to the date of death from any cause. |
| Secondary | Overall Response Rate (ORR) in Patients After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | Up to 3 years | The number of participants with a CR or PR response after receiving ipilimumab, nivolumab, tacrolimus, and prednisone. |
| Secondary | Rate of Allograft Loss After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | Up to 3 years | Number of patients who experienced allograft loss after receiving nivolumab, ipilimumab, tacrolimus, and prednisone. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone | At 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response (CR or PR) Rate (ORR) After Receiving Nivolumab, Tacrolimus, and Prednisone | Up to 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Allograft Loss After Receiving Nivolumab, Tacrolimus, and Prednisone | Up to 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Progression-free Survival After Receiving Nivolumab, Tacrolimus, and Prednisone | Up to 4 months | days | MEAN | |
| SECONDARY | Duration of Overall Survival After Receiving Nivolumab, Tacrolimus, and Prednisone | Up to 3 years | months | MEDIAN | |
| SECONDARY | Overall Response Rate (ORR) in Patients After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | Up to 3 years | Two participants who completed the initial treatment period did not start the second, optional treatment period due to disease progression or death. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Allograft Loss After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | Up to 3 years | Two participants who completed the initial treatment period did not start the second, optional treatment period due to disease progression or death. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone | Nivolumab, Tacrolimus, and Prednisone | Complete response (CR), partial response (PR) or stable disease (SD) without allograft loss | 0 | Participants | |
| Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone | Nivolumab, Tacrolimus, and Prednisone | Progressive Disease (PD) without allograft loss | 8 | Participants | |
| Objective Response (CR or PR) Rate (ORR) After Receiving Nivolumab, Tacrolimus, and Prednisone | Nivolumab, Tacrolimus, and Prednisone | Complete response (CR) or Partial Response (PR) | 0 | Participants | |
| Objective Response (CR or PR) Rate (ORR) After Receiving Nivolumab, Tacrolimus, and Prednisone | Nivolumab, Tacrolimus, and Prednisone | Progressive Disease (PD) | 8 | Participants | |
| Rate of Allograft Loss After Receiving Nivolumab, Tacrolimus, and Prednisone | Nivolumab, Tacrolimus, and Prednisone | Experienced allograft loss | 0 | Participants | |
| Rate of Allograft Loss After Receiving Nivolumab, Tacrolimus, and Prednisone | Nivolumab, Tacrolimus, and Prednisone | Did not experience allograft loss | 8 | Participants | |
| Duration of Progression-free Survival After Receiving Nivolumab, Tacrolimus, and Prednisone | Nivolumab, Tacrolimus, and Prednisone | 59 | Full Range 54 to 70 | days | |
| Duration of Overall Survival After Receiving Nivolumab, Tacrolimus, and Prednisone | Nivolumab, Tacrolimus, and Prednisone | 9.1 | Full Range 1.9 to 37.0 | months | |
| Overall Response Rate (ORR) in Patients After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | Complete or Partial Response (CR or PR) | 2 | Participants | |
| Overall Response Rate (ORR) in Patients After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | Progressive Disease (PD) | 4 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Nivolumab, Tacrolimus, and Prednisone | STARTED | Treatment | 12 | |
| Nivolumab, Tacrolimus, and Prednisone | COMPLETED | Treatment | 8 | |
| Nivolumab, Tacrolimus, and Prednisone | NOT COMPLETED | Treatment | 4 | |
| Nivolumab, Ipilimumab, Tacrolimus, Pred | STARTED | Treatment | 6 | |
| Nivolumab, Ipilimumab, Tacrolimus, Pred | COMPLETED | Treatment | 6 | |
| Nivolumab, Ipilimumab, Tacrolimus, Pred | NOT COMPLETED | Treatment | 0 |
Source ClinicalTrials.gov
Adverse events214
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 | Abdominal pain | Gastrointestinal disorders | Nivolumab, Tacrolimus, and Prednisone | 1 | 10 | |
| other | Abdominal pain | Gastrointestinal disorders | Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | 1 | 6 | |
| other | Alanine aminotransferase increased | Investigations | Nivolumab, Tacrolimus, and Prednisone | 1 | 10 | |
| other | Alanine aminotransferase increased | Investigations | Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | 1 | 6 | |
| other | Alkaline phosphatase increased | Investigations | Nivolumab, Tacrolimus, and Prednisone | 1 | 10 | |
| other | Alkaline phosphatase increased | Investigations | Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | 1 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Nivolumab, Tacrolimus, and Prednisone | 5 | 10 | |
| other | Anemia | Blood and lymphatic system disorders | Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | 3 | 6 | |
| other | Anorexia | Metabolism and nutrition disorders | Nivolumab, Tacrolimus, and Prednisone | 0 | 10 | |
| other | Anorexia | Metabolism and nutrition disorders | Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | 2 | 6 |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab, Tacrolimus, and Prednisone | 4 | 10 |
| Total, all-cause mortality | Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | 3 | 6 |
| Total, other adverse events | Nivolumab, Tacrolimus, and Prednisone | 9 | 10 |
| Total, other adverse events | Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | 6 | 6 |
| Total, serious adverse events | Nivolumab, Tacrolimus, and Prednisone | 6 | 10 |
| Total, serious adverse events | Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | 6 | 6 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186691 | The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies | CARDUCCI, MICHAEL A; BEUMER, JAN HENDRIK; GENTZLER, RYAN; LIU, GLENN; MESSERSMITH, WELLS A.; RUIZ, JIMMY | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nivolumab, Tacrolimus, and Prednisone vs Ipilimumab, Nivolumab, Tacrolimus, and Prednisone: deaths from any cause | Trial comparisons |
| Nivolumab, Tacrolimus, and Prednisone vs Ipilimumab, Nivolumab, Tacrolimus, and Prednisone: serious adverse events | Trial comparisons |
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/NCT03816332
GET https://conductscience.org/api/trials/v1/NCT03816332/events?page=2