Trial · NCT02500797

Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery

NCT02500797, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-06-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery. Trials, record NCT02500797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02500797

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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 Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery
NCT number: NCT02500797
Status: Completed
Phases: Phase 2
Enrollment: 164 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Locally Advanced Bone Sarcoma, Locally Advanced Dedifferentiated Liposarcoma, Locally Advanced Gastrointestinal Stromal Tumor, Locally Advanced Soft Tissue Sarcoma, Metastatic Bone Sarcoma, Metastatic Liposarcoma, Metastatic Soft Tissue Sarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Metastatic Unresectable Sarcoma, Pleomorphic Liposarcoma, Stage III Bone Sarcoma AJCC v7, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Bone Sarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7, Stage IVA Bone Sarcoma AJCC v7, Stage IVB Bone Sarcoma AJCC v7, Unresectable Bone Sarcoma, Unresectable Dedifferentiated Liposarcoma, Unresectable Liposarcoma, Unresectable Malignant Gastrointestinal Stromal Tumor, Unresectable Soft Tissue Sarcoma
Interventions: Ipilimumab, Laboratory Biomarker Analysis, Nivolumab, Quality-of-Life Assessment
First posted: 2015-07-17
Last updated: 2023-10-17
Results first posted: 2020-06-16

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Who Achieved a Confirmed Response	Up to 44 months	The number of participants who achieved a confirmed response is defined as the number of patients having a best objective tumor status of complete response (CR) or partial response (PR) lasting at least 4 weeks as determined using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites).
Secondary	Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Regardless of Attribution	Up to 4 weeks after completion of study treatment	The number of participants who experienced at least one grade 3 or higher adverse event (AE) regardless of attribution. AEs are graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 beginning April 1, 2018).
Secondary	Duration of Response	Time from first response to progression, assessed up to 3 years	Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir).
Secondary	6-Month Clinical Benefit Rate [Initial Cohort]	At 6 months	The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
Secondary	6-Month Clinical Benefit Rate [Expansion LPS and UPS/MFH Cohorts Only]	At 6 months	The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
Secondary	6-Month Clinical Benefit Rate [Expansion GIST Cohort Only]	At 6 months	The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
Secondary	Progression-free Survival (PFS)	Time from randomization to first of either disease progression or death from any cause, assessed up to 3 years	Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. (PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir).
Secondary	Overall Survival (OS)	Time from randomization to death from any cause, assessed up to 3 years	Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Other	PD-L1 Expression Assessed Using Immunohistochemistry (IHC)	Up to 3 years	Categorical data analysis and logistic regression will be used to evaluate the associations between PD-L1 expression (by IHC) and clinical outcome (e.g., response, clinical benefit, progression-free survival, and survival). Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints.
Other	Change in Selected Biomarkers Measured in Serial Peripheral Blood	Baseline to up to 3 years	Summary statistics will be used to for describing changes across time. The time course of biomarker outcomes will be investigated graphically, by summary plots or individual patient plots. If there is suggestion of meaningful trend, methods such as linear mixed models may be used to characterize the pattern of change over time. Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Who Achieved a Confirmed Response	Up to 44 months	Participants who completed the study and were evaluable for the primary endpoint are included in this analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Regardless of Attribution	Up to 4 weeks after completion of study treatment	Randomized patients who received treatment (i.e. exclude cancel patients).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Response	Time from first response to progression, assessed up to 3 years	Participants who achieved a confirmed response are included in this analysis.	months	MEDIAN
SECONDARY	6-Month Clinical Benefit Rate [Initial Cohort]	At 6 months	Randomized Initial Cohort participants who received treatment (i.e. exclude cancel patients) Only.	percentage of participants	NUMBER
SECONDARY	6-Month Clinical Benefit Rate [Expansion LPS and UPS/MFH Cohorts Only]	At 6 months	Randomized Expansion LPS and UPS/MFH Cohorts Participants who received treatment Only	percentage of participants	NUMBER
SECONDARY	6-Month Clinical Benefit Rate [Expansion GIST Cohort Only]	At 6 months	Randomized Expansion GIST Cohort Participants who received treatment Only.	percentage of participants	NUMBER
SECONDARY	Progression-free Survival (PFS)	Time from randomization to first of either disease progression or death from any cause, assessed up to 3 years		months	MEDIAN
SECONDARY	Overall Survival (OS)	Time from randomization to death from any cause, assessed up to 3 years		months	MEDIAN
OTHER_PRE_SPECIFIED	PD-L1 Expression Assessed Using Immunohistochemistry (IHC)	Up to 3 years
OTHER_PRE_SPECIFIED	Change in Selected Biomarkers Measured in Serial Peripheral Blood	Baseline to up to 3 years

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group62

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants Who Achieved a Confirmed Response	Initial Single		2	Participants
Number of Participants Who Achieved a Confirmed Response	Initial Dual		6	Participants
Number of Participants Who Achieved a Confirmed Response	LPS Single		1	Participants
Number of Participants Who Achieved a Confirmed Response	LPS Dual		2	Participants
Number of Participants Who Achieved a Confirmed Response	UPS/MFH Single		1	Participants
Number of Participants Who Achieved a Confirmed Response	UPS/MFH Dual		2	Participants
Number of Participants Who Achieved a Confirmed Response	GIST Single		0	Participants
Number of Participants Who Achieved a Confirmed Response	GIST Dual		0	Participants
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Regardless of Attribution	Initial Single	Grade 3 Event	19	Participants
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Regardless of Attribution	Initial Dual	Grade 3 Event	25	Participants

1 to 10 of 62Source ClinicalTrials.gov

See all 62 results by group

Participant flow32

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Initial Cohort - Arm I (Nivolumab)	43
Overall Study	STARTED	Initial Cohort - Arm II (Nivolumab, Ipilimumab)	42
Overall Study	STARTED	Expansion LPS Cohort - Arm I (Nivolumab)	15
Overall Study	STARTED	Expansion LPS Cohort - Arm II (Nivolumab, Ipilimumab)	14
Overall Study	STARTED	Expansion UPS/MFH Cohort - Arm I (Nivolumab)	14
Overall Study	STARTED	Expansion UPS/MFH Cohort - Arm II (Nivolumab, Ipilimumab)	15
Overall Study	STARTED	Expansion GIST Cohort - Arm I (Nivolumab)	10
Overall Study	STARTED	Expansion GIST Cohort - Arm II (Nivolumab, Ipilimumab)	11
Overall Study	Arm I Crossover	Initial Cohort - Arm I (Nivolumab)	4
Overall Study	Arm I Crossover	Initial Cohort - Arm II (Nivolumab, Ipilimumab)	0

1 to 10 of 32Source ClinicalTrials.gov

See all 32 participant flow

Adverse events1,752

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	Initial Single	10	42	13
other	Anemia	Blood and lymphatic system disorders	Initial Dual	10	42	16
other	Anemia	Blood and lymphatic system disorders	LPS Single	3	15	5
other	Anemia	Blood and lymphatic system disorders	LPS Dual	3	14	6
other	Anemia	Blood and lymphatic system disorders	UPS/MFH Single	2	13	3
other	Anemia	Blood and lymphatic system disorders	UPS/MFH Dual	3	14	7
other	Anemia	Blood and lymphatic system disorders	GIST Single	1	10	1
other	Anemia	Blood and lymphatic system disorders	GIST Dual	1	11	1
other	Leukocytosis	Blood and lymphatic system disorders	Initial Single	0	42	0
other	Leukocytosis	Blood and lymphatic system disorders	Initial Dual	1	42	1

1 to 10 of 1,752Source ClinicalTrials.gov

See all 1,752 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Initial Single	37	43
Total, all-cause mortality	Initial Dual	34	42
Total, all-cause mortality	LPS Single	11	15
Total, all-cause mortality	LPS Dual	10	14
Total, all-cause mortality	UPS/MFH Single	10	14
Total, all-cause mortality	UPS/MFH Dual	7	15
Total, all-cause mortality	GIST Single	8	10
Total, all-cause mortality	GIST Dual	7	11
Total, other adverse events	Initial Single	39	42
Total, other adverse events	Initial Dual	40	42

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29370992	DERIVED	PubMed
39343511	DERIVED	PubMed

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
U10CA180821	Alliance for Clinical Trials in Oncology Operations Center	Galanis, Evanthia; Hahn, Olwen; Kozono, David	ALLIANCE NCTN FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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