Trial · NCT02648997

An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent Meningioma

NCT02648997, Phase 2, Active not recruiting, Dana-Farber Cancer Institute; results first posted 2026-01-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent Meningioma. Trials, record NCT02648997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02648997

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent Meningioma
NCT number: NCT02648997
Status: Active not recruiting
Phases: Phase 2
Enrollment: 40 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Meningiomas
Interventions: Nivolumab - 240 mg, Ipilimumab - 1 mg/kg, Nivolumab - 480 mg, Nivolumab - 3 mg/kg, External Beam RT, Nivolumab - 1 mg/kg, Ipilimumab - 3 mg/kg
First posted: 2016-01-07
Last updated: 2026-07-10
Results first posted: 2026-01-26

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Number of Participants Without Disease Progression At Six Months Following Initiation Of Study Therapy	6 months	To evaluate the anti-tumor activity for single-agent nivolumab (cohort 1) or nivolumab plus ipilimumab following radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma.
Secondary	Both Cohorts: Median Progression-Free Survival	2 years	To evaluate additional measures of anti-tumor activity of single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma
Secondary	Both Cohorts: Median Overall Survival	2 years	To evaluate additional measures of anti-tumor activity of single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma
Secondary	Both Cohorts: Objective Radiologic Response Rate	2 years	To evaluate additional measures of anti-tumor activity of single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma
Secondary	Both Cohorts: Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0.	2 years	1.2.1 To evaluate the safety and tolerability of single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2) among patients with recurrent/progressive grade I, II or III meningioma
Other	Evaluate Circulating Immune Cell Subsets and Cytokines as Systemic Immune Correlative Markers	2 years	Using fluorescence activated cell sorting (FACS), the absolute CD4 T cell count will be determined and phenotyping of T effector cells (CD4+CD69+) and T regulatory cells (CD4+CD25+FoxP3+) with determination of absolute number of naive, effector and regulatory T cells as well as percents/ratios of total population will also be determined. Soluble factors such as cytokines, chemokines, soluble receptors and antibodies to tumor antigens will be measured via commercially available multiplex assays and enzyme-linked immunosorbent assays (ELISA)
Other	Evaluate Archival Tumor Expression of PD-L1 and PD-1 Expressing Tumor Infiltrating Lymphocytes	2 years	To evaluate correlative biomarkers of systemic immune response among patients with recurrent/progressive grade II or III meningioma treated with single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2)
Other	Evaluate Archival Tumor Expression of Immune Gene Expression Signature Utilizing the Nanostring Assay	2 years	To evaluate correlative biomarkers of systemic immune response among patients with recurrent/progressive grade II or III meningioma treated with single-agent nivolumab (cohort 1) and nivolumab plus ipilimumab after radiation therapy (cohort 2)
Other	Assess Mean Changes From Baseline in the Level of Function Score for Each Domain of the Neurologic Assessment in Neuro-Oncology (NANO) Scale	2 years	Evaluation Of Neurologic Function As Measured By The NANO Scale.
Other	Determine Difference in Tumor Growth Rates Before and After Treatment That Would Allow Detection of Treatment Efficacy.	2 years	Evaluation of change in tumor growth rate as measured by volumetric analysis

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Without Disease Progression At Six Months Following Initiation Of Study Therapy	6 months	Subjects who withdrew consent to be followed or otherwise came off-study prior to reaching 6 months progression-free are not considered evaluable for PFS6 and are therefore not included here. This includes 2 COH 1 subjects and 1 COH 2 subject on Dose Level 0A. Another COH 2 subject on Dose Level 0A Withdrew consent to be followed without ever having received any study tx and is also not included in this dataset.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Both Cohorts: Median Progression-Free Survival	2 years
SECONDARY	Both Cohorts: Median Overall Survival	2 years
SECONDARY	Both Cohorts: Objective Radiologic Response Rate	2 years
SECONDARY	Both Cohorts: Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0.	2 years
OTHER_PRE_SPECIFIED	Evaluate Circulating Immune Cell Subsets and Cytokines as Systemic Immune Correlative Markers	2 years
OTHER_PRE_SPECIFIED	Evaluate Archival Tumor Expression of PD-L1 and PD-1 Expressing Tumor Infiltrating Lymphocytes	2 years
OTHER_PRE_SPECIFIED	Evaluate Archival Tumor Expression of Immune Gene Expression Signature Utilizing the Nanostring Assay	2 years
OTHER_PRE_SPECIFIED	Assess Mean Changes From Baseline in the Level of Function Score for Each Domain of the Neurologic Assessment in Neuro-Oncology (NANO) Scale	2 years
OTHER_PRE_SPECIFIED	Determine Difference in Tumor Growth Rates Before and After Treatment That Would Allow Detection of Treatment Efficacy.	2 years

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group3

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

Outcome	Group	Value	Units
Number of Participants Without Disease Progression At Six Months Following Initiation Of Study Therapy	Cohort 1 (Original Cohort): Nivolumab Monotherapy	10	Participants
Number of Participants Without Disease Progression At Six Months Following Initiation Of Study Therapy	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab	3	Participants
Number of Participants Without Disease Progression At Six Months Following Initiation Of Study Therapy	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab	10	Participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort 1 (Original Cohort): Nivolumab Monotherapy	25
Overall Study	STARTED	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab	3
Overall Study	STARTED	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab	12
Overall Study	COMPLETED	Cohort 1 (Original Cohort): Nivolumab Monotherapy	25
Overall Study	COMPLETED	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab	3
Overall Study	COMPLETED	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab	11
Overall Study	NOT COMPLETED	Cohort 1 (Original Cohort): Nivolumab Monotherapy	0
Overall Study	NOT COMPLETED	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab	0
Overall Study	NOT COMPLETED	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab	1

Source ClinicalTrials.gov

Adverse events453

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
other	Anemia	Blood and lymphatic system disorders	Cohort 1 (Original Cohort): Nivolumab Monotherapy	5	25
other	Anemia	Blood and lymphatic system disorders	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab	0	3
other	Anemia	Blood and lymphatic system disorders	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab	3	11
other	Hypothyroidism	Endocrine disorders	Cohort 1 (Original Cohort): Nivolumab Monotherapy	2	25
other	Hypothyroidism	Endocrine disorders	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab	2	3
other	Hypothyroidism	Endocrine disorders	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab	2	11
other	Blurred vision	Eye disorders	Cohort 1 (Original Cohort): Nivolumab Monotherapy	4	25
other	Blurred vision	Eye disorders	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab	0	3
other	Blurred vision	Eye disorders	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab	1	11
other	Eye pain	Eye disorders	Cohort 1 (Original Cohort): Nivolumab Monotherapy	2	25

1 to 10 of 453Source ClinicalTrials.gov

See all 453 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1 (Original Cohort): Nivolumab Monotherapy	20	22
Total, all-cause mortality	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab	2	3
Total, all-cause mortality	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab	1	9
Total, other adverse events	Cohort 1 (Original Cohort): Nivolumab Monotherapy	25	25
Total, other adverse events	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab	3	3
Total, other adverse events	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab	11	11
Total, serious adverse events	Cohort 1 (Original Cohort): Nivolumab Monotherapy	11	25
Total, serious adverse events	Cohort 2 - Dose Level 0: Nivolumab in Combination With Ipilimumab	2	3
Total, serious adverse events	Cohort 2 - Dose Level 0A: Nivolumab in Combination With Ipilimumab	7	11

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

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.

GET https://conductscience.org/api/trials/v1/NCT02648997

GET https://conductscience.org/api/trials/v1/NCT02648997/events?page=2

API reference For AI assistants