Trial · NCT02304458
Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas
NCT02304458, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-01-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas. Trials, record NCT02304458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02304458
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas
- NCT number
- NCT02304458
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 140 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Metastatic Melanoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Hodgkin Lymphoma, Recurrent Malignant Solid Neoplasm, Recurrent Melanoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Rhabdomyosarcoma, Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Refractory Hodgkin Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Melanoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Rhabdomyosarcoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Unresectable Melanoma
- Interventions
- Ipilimumab, Laboratory Biomarker Analysis, Nivolumab, Pharmacological Study
- First posted
- 2014-12-02
- Last updated
- 2023-10-17
- Results first posted
- 2023-01-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab | 28 days | The frequency (%) of patients experiencing a dose limiting toxicity at least possibly attributable to nivolumab as a single agent or in combination with ipilimumab by study part and dose level. |
| Primary | Antitumor Effect of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 5 years | Frequency of disease response (best overall response of partial or complete response) assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR by study part and dose level. |
| Secondary | Pharmacodynamics of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 28 days | Median (min,max) concentration by protein, study part, and dose level. |
| Secondary | Area Under the Drug Concentration Curve of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 15 days | The median (min,max) of the area under the drug concentration curve for nivolumab as a single agent or in combination with ipilimumab by study part and dose level. Measured during cycle 1 at 0, 24,72,192, and 360 hours post-dose. |
| Secondary | Half-life of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 15 days | The median (min,max) of the half-life of nivolumab as a single agent or in combination with ipilimumab by study part and dose level. Measured during cycle 1 at 0, 24, 72, 192, and 360 hours post-dose. The reported half-life was calculated using a linear regression of the log (concentration) versus time data for days 4, 8 and 15. |
| Secondary | Maximum Serum Concentration of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 15 days | Median (min,max) of the maximum serum concentration of nivolumab as a single agent or in combination with ipilimumab by study part and dose level. Measured during cycle 1 at 0, 24, 72, 192, and 360 hours post-dose. |
| Secondary | Minimum Serum Concentration of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 15 days | Median (min,max) of the minimum serum concentration of nivolumab as a single agent or in combination with ipilimumab by study part and dose level. Measured during cycle 1 at 0, 24, 72, 192, and 360 hours post-dose. |
| Secondary | Clearance of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 15 days | Median (min,max) of the clearance of nivolumab as a single agent or in combination with ipilimumab by study part and dose level. Measured during cycle 1 at 0, 24, 72, 192, and 360 hours post-dose. |
| Secondary | PD-L1 Expression of Nivolumab as a Single Agent or in Combination With Ipilimumab | Cycle 1 (21 days) | Median (min, max) of PD-L1 expression levels by study part, dose level, and disease cohort. |
| Secondary | Biomarker Expression Analysis of Nivolumab as a Single Agent or in Combination With Ipilimumab | Cycle 1 (21 days) | Median (min, max) expression levels by biomarker, dose level, study part, and disease cohort. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab | 28 days | All Eligible patients | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Antitumor Effect of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 5 years | All Eligible patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacodynamics of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 28 days | Data were not and will never be collected | ||
| SECONDARY | Area Under the Drug Concentration Curve of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 15 days | All eligible patients with data collected. Data not collected for Parts C, D, and E | hr*ug/mL | MEDIAN |
| SECONDARY | Half-life of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 15 days | All eligible patients with data collected. Data not collected for Parts C, D, and E | hours | MEDIAN |
| SECONDARY | Maximum Serum Concentration of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 15 days | All eligible patients with data collected | ug/mL | MEDIAN |
| SECONDARY | Minimum Serum Concentration of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 15 days | All eligible patients with data collected | ug/mL | MEDIAN |
| SECONDARY | Clearance of Nivolumab as a Single Agent or in Combination With Ipilimumab | Up to 15 days | All eligible patients with data collected. Data not collected for Parts C, D, and E | mL/hr/kg | MEDIAN |
| SECONDARY | PD-L1 Expression of Nivolumab as a Single Agent or in Combination With Ipilimumab | Cycle 1 (21 days) | All Eligible patients | percent | MEDIAN |
| SECONDARY | Biomarker Expression Analysis of Nivolumab as a Single Agent or in Combination With Ipilimumab | Cycle 1 (21 days) | Data were not and will never be collected |
Source ClinicalTrials.gov
Results by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab | Part A: 3 mg/kg Nivolumab | 0 | Participants | ||
| Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab | Part A PK: 3 mg/kg Nivolumab | 0 | Participants | ||
| Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab | Part B: 3 mg/kg Nivolumab | 5 | Participants | ||
| Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab | Part C: 1mg/kg Nivolumab and 1mg/kg Ipilimumab | 0 | Participants | ||
| Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab | Part C: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 0 | Participants | ||
| Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab | Part C PK: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 1 | Participants | ||
| Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab | Part D: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 1 | Participants | ||
| Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab | Part E: 1mg/kg Nivolumab and 3mg/kg Ipilimumab | 1 | Participants | ||
| Antitumor Effect of Nivolumab as a Single Agent or in Combination With Ipilimumab | Part A: 3 mg/kg Nivolumab | 0 | Participants | ||
| Antitumor Effect of Nivolumab as a Single Agent or in Combination With Ipilimumab | Part A PK: 3 mg/kg Nivolumab | 0 | Participants |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: 3 mg/kg Nivolumab | 7 | |
| Overall Study | STARTED | Part A PK: 3 mg/kg Nivolumab | 6 | |
| Overall Study | STARTED | Part B: 3 mg/kg Nivolumab | 72 | |
| Overall Study | STARTED | Part C: 1mg/kg Nivolumab and 1mg/kg Ipilimumab | 6 | |
| Overall Study | STARTED | Part C: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 6 | |
| Overall Study | STARTED | Part C PK: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 6 | |
| Overall Study | STARTED | Part D: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 29 | |
| Overall Study | STARTED | Part E: 1mg/kg Nivolumab and 3mg/kg Ipilimumab | 8 | |
| Overall Study | COMPLETED | Part A: 3 mg/kg Nivolumab | 0 | |
| Overall Study | COMPLETED | Part A PK: 3 mg/kg Nivolumab | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events6,064
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 distension | Gastrointestinal disorders | Part A: 3 mg/kg Nivolumab | 0 | 7 | |
| other | Abdominal distension | Gastrointestinal disorders | Part A PK: 3 mg/kg Nivolumab | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part B: 3 mg/kg Nivolumab | 2 | 72 | |
| other | Abdominal distension | Gastrointestinal disorders | Part C: 1mg/kg Nivolumab and 1mg/kg Ipilimumab | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part C: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part C PK: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Part D: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 6 | 29 | |
| other | Abdominal distension | Gastrointestinal disorders | Part E: 1mg/kg Nivolumab and 3mg/kg Ipilimumab | 3 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | Part A: 3 mg/kg Nivolumab | 1 | 7 | |
| other | Abdominal pain | Gastrointestinal disorders | Part A PK: 3 mg/kg Nivolumab | 2 | 6 |
1 to 10 of 6,064Source ClinicalTrials.gov
See all 6,064 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: 3 mg/kg Nivolumab | 3 | 7 |
| Total, all-cause mortality | Part A PK: 3 mg/kg Nivolumab | 3 | 6 |
| Total, all-cause mortality | Part B: 3 mg/kg Nivolumab | 38 | 72 |
| Total, all-cause mortality | Part C: 1mg/kg Nivolumab and 1mg/kg Ipilimumab | 2 | 6 |
| Total, all-cause mortality | Part C: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 4 | 6 |
| Total, all-cause mortality | Part C PK: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 4 | 6 |
| Total, all-cause mortality | Part D: 3mg/kg Nivolumab and 1mg/kg Ipilimumab | 19 | 29 |
| Total, all-cause mortality | Part E: 1mg/kg Nivolumab and 3mg/kg Ipilimumab | 1 | 8 |
| Total, other adverse events | Part A: 3 mg/kg Nivolumab | 7 | 7 |
| Total, other adverse events | Part A PK: 3 mg/kg Nivolumab | 6 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
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 |
|---|---|---|---|---|---|
| UM1CA097452 | Pediatric Phase 1/Pilot Consortium | WEIGEL, BRENDA J. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2009 to 2018 |
Source NIH RePORTER
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/NCT02304458
GET https://conductscience.org/api/trials/v1/NCT02304458/results?page=2