Trial · NCT02939300
Ipilimumab and Nivolumab in Leptomeningeal Metastases
NCT02939300, Phase 2, Completed, Massachusetts General Hospital; results first posted 2022-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ipilimumab and Nivolumab in Leptomeningeal Metastases. Trials, record NCT02939300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02939300
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ipilimumab and Nivolumab in Leptomeningeal Metastases
- NCT number
- NCT02939300
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Leptomeningeal Carcinomatosis
- Interventions
- Nivolumab, Ipilimumab
- First posted
- 2016-10-20
- Last updated
- 2025-11-14
- Results first posted
- 2022-11-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Overall Survival | 3 months | Overall Survival (OS) is defined as the time from registration to death due to any cause, or censored at date last known alive. |
| Secondary | Percentage of Participants With Treatment-related Adverse Events | 2 years | Grade 3 or 4 treatment-related adverse events occurring in at least 15% of participants, based on CTCAE v4.0 criteria. |
| Secondary | Cumulative Incidence of Progressive Disease at 3 Months for Intracranial Sites | 3 months post-treatment | Cumulative incidence describes the average probability of developing progressive disease (PD) by immunotherapy response assessment for neuro-oncology (iRANO) criteria. PD is defined as any of the following: (1) \>/= 25% increase in 2-dimensional contrast lesions; (2) significant worsened changes on T2-weighted MRI scans; (3) new lesion; or (4) significant clinical decline. Confirmation of progressive disease is based on follow-up imaging for participants without significant clinical decline. |
| Secondary | Cumulative Incidence of Progressive Disease at 3 Months for Extracranial Sites | 3 months post-treatment | Cumulative incidence describes the average probability of developing progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. PD is defined as any of the following: (1) \>/= 25% increase in 2-dimensional contrast lesions; (2) significant worsened changes on T2-weighted MRI scans; (3) new lesion; or (4) significant clinical decline. Confirmation of progressive disease is based on follow-up imaging for participants without significant clinical decline. |
| Secondary | Number of Participants With Leptomeningeal Disease (LMD) Response Post-Treatment | 6-9 weeks after treatment initiation | Cerebrospinal fluid (CSF) collection and cytology is done 6-9 weeks after treatment initiation to assess for LMD response, especially complete response or partial response. Complete Response is defined as: * Reversion to negative CSF cytology (or NA) * Disappearance of all disease related symptoms present prior to therapy (or NA) * Complete disappearance of all detectable radiographic evidence of disease (or NA). Partial Response is defined as: * \> 50% decrease in malignant CSF cytology * Improvement in neurologic symptoms or no worsening of symptoms * Improvement in radiographic evidence of disease. No new sites of measurable or assessable central nervous system (CNS) disease. |
| Secondary | Extracranial Progression-Free Survival | 2 years | Extracranial Progression-Free Survival (EPFS) is defined as the time from first dose of study drug to documented extracranial disease progression or death, whichever occurs first. Extracranial disease progression is assessed with CT scans of the chest, abdomen, and pelvis, by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria and immune-related response criteria (irRC) criteria. Progression is defined using RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The follow-up of participants who have neither died nor progressed at the time of analysis will be censored at the date of last adequate disease assessment. |
| Secondary | Intracranial Progression-Free Survival | 2 years | Intracranial Progression-Free Survival (IPFS) is defined as the time from first dose of study drug to documented intracranial disease progression or death, whichever occurs first. Intracranial disease progression is assessed with CT or MRI scans of the brain, using the Response assessment in neuro-oncology (RANO) criteria, which defines progression as: * ≥ 25% increase in in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline; or * Presence of new lesions; or * Worsening of clinical/neurologic status (unless clearly unrelated to the cancer); or * Worsening of non-measurable disease. The follow-up of participants who have neither died nor progressed at the time of analysis will be censored at the date of last adequate disease assessment. |
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 | Percentage of Participants With Overall Survival | 3 months | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Treatment-related Adverse Events | 2 years | percentage of participants | NUMBER | |
| SECONDARY | Cumulative Incidence of Progressive Disease at 3 Months for Intracranial Sites | 3 months post-treatment | percentage of participants | NUMBER | |
| SECONDARY | Cumulative Incidence of Progressive Disease at 3 Months for Extracranial Sites | 3 months post-treatment | percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Leptomeningeal Disease (LMD) Response Post-Treatment | 6-9 weeks after treatment initiation | Due to the clinical nature of LMD with rapidly progressive disease, the majority participants did not undergo post-treatment lumbar punctures before going off study or passing away. CSF cytology 6-9 weeks after treatment initiation was only obtained on 4 participants, which does not provide statistically meaningful interpretation of data. Individual results are reported below. | participants | NUMBER |
| SECONDARY | Extracranial Progression-Free Survival | 2 years | months | MEDIAN | |
| SECONDARY | Intracranial Progression-Free Survival | 2 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Overall Survival | Combination Of Nivolumab with Ipilimumab | 44 | 90% Confidence Interval 24 to 66 | percentage of participants | |
| Percentage of Participants With Treatment-related Adverse Events | Combination Of Nivolumab with Ipilimumab | 33 | 90% Confidence Interval 16 to 55 | percentage of participants | |
| Cumulative Incidence of Progressive Disease at 3 Months for Intracranial Sites | Combination Of Nivolumab with Ipilimumab | 45 | 90% Confidence Interval 25 to 80 | percentage of participants | |
| Cumulative Incidence of Progressive Disease at 3 Months for Extracranial Sites | Combination Of Nivolumab with Ipilimumab | 33 | 90% Confidence Interval 8 to 62 | percentage of participants | |
| Number of Participants With Leptomeningeal Disease (LMD) Response Post-Treatment | Combination Of Nivolumab with Ipilimumab | Complete Response | 0 | participants | |
| Number of Participants With Leptomeningeal Disease (LMD) Response Post-Treatment | Combination Of Nivolumab with Ipilimumab | Partial Response | 1 | participants | |
| Extracranial Progression-Free Survival | Combination Of Nivolumab with Ipilimumab | 1.94 | 90% Confidence Interval 1.35 to 4.44 | months | |
| Intracranial Progression-Free Survival | Combination Of Nivolumab with Ipilimumab | 1.93 | 90% Confidence Interval 1.28 to 2.66 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination Of Nivolumab with Ipilimumab | 18 | |
| Overall Study | COMPLETED | Combination Of Nivolumab with Ipilimumab | 18 | |
| Overall Study | NOT COMPLETED | Combination Of Nivolumab with Ipilimumab | 0 |
Source ClinicalTrials.gov
Adverse events174
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 | Combination Of Nivolumab with Ipilimumab | 5 | 18 | 6 |
| other | Acidosis | Metabolism and nutrition disorders | Combination Of Nivolumab with Ipilimumab | 1 | 18 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | Combination Of Nivolumab with Ipilimumab | 1 | 18 | 1 |
| other | Agitation | Psychiatric disorders | Combination Of Nivolumab with Ipilimumab | 1 | 18 | 1 |
| other | Alanine aminotransferase increased | Investigations | Combination Of Nivolumab with Ipilimumab | 5 | 18 | 10 |
| other | Alkaline phosphatase increased | Investigations | Combination Of Nivolumab with Ipilimumab | 2 | 18 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Combination Of Nivolumab with Ipilimumab | 4 | 18 | 8 |
| other | Anorexia | Metabolism and nutrition disorders | Combination Of Nivolumab with Ipilimumab | 9 | 18 | 11 |
| other | Apnea | Respiratory, thoracic and mediastinal disorders | Combination Of Nivolumab with Ipilimumab | 1 | 18 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Combination Of Nivolumab with Ipilimumab | 2 | 18 | 2 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Of Nivolumab with Ipilimumab | 13 | 18 |
| Total, other adverse events | Combination Of Nivolumab with Ipilimumab | 17 | 18 |
| Total, serious adverse events | Combination Of Nivolumab with Ipilimumab | 10 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34642329 | 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/NCT02939300
GET https://conductscience.org/api/trials/v1/NCT02939300/events?page=2