Trial · NCT02553642

Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260)

NCT02553642, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2025-07-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260). Trials, record NCT02553642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02553642

On this page

Trial

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

Title: Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260)
NCT number: NCT02553642
Status: Completed
Phases: Phase 2
Enrollment: 81 participants, actual
Lead sponsor: Memorial Sloan Kettering Cancer Center
Conditions: Bladder Cancer, Melanoma
Interventions: Nivolumab, Nivolumab plus Ipilimumab
First posted: 2015-09-17
Last updated: 2025-07-22
Results first posted: 2025-07-22

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Confirmed Objective Response in Bladder Cancer Participants to Nivolumab Monotherapy	From treatment start, up to 2 years from initial dose of nivolumab.	Primary clinical endpoint was proportion of patients who achieve a confirmed objective response rate (per RECIST 1.1) to nivolumab monotherapy in bladder cancer patients progressing on initial nivolumab monotherapy. 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.
Primary	Confirmed Objective Response for Bladder Cancer Patients to Ipilimumab and Nivolumab Combination Therapy in Patients Progressing on Initial Nivolumab Monotherapy	From treatment start, up to 2 years from initial dose of nivolumab.	Primary clinical endpoint was proportion of patients who achieve a confirmed objective response rate (per RECIST 1.1) to ipilimumab and nivolumab combination therapy in bladder cancer patients progressing on initial nivolumab monotherapy.
Secondary	Tumor Mutational Burden for Evaluable Bladder Cancer Participants	At baseline	Primary correlative objective was to obtain information on mutational load and obtain preliminary prospective data on whether this factor is predictive of response to immunotherapy. Receiver operator characteristic (ROC) curves with mutational load as a continuous measure was used to estimate the area under the curve (AUC) to assess the detectability of responders. This was applicable to Bladder cohort.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Confirmed Objective Response in Bladder Cancer Participants to Nivolumab Monotherapy	From treatment start, up to 2 years from initial dose of nivolumab.	Only Bladder Cancer Patients were evaluated	percentage of participants with PR/CR	NUMBER
PRIMARY	Confirmed Objective Response for Bladder Cancer Patients to Ipilimumab and Nivolumab Combination Therapy in Patients Progressing on Initial Nivolumab Monotherapy	From treatment start, up to 2 years from initial dose of nivolumab.	Only Bladder Cancer Participants were evaluated	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Tumor Mutational Burden for Evaluable Bladder Cancer Participants	At baseline	Evaluable bladder cancer patients were analyzed	mut/Mb	MEDIAN

Source ClinicalTrials.gov

Results by group7

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

Outcome	Group	Category	Value	Spread	Units
Confirmed Objective Response in Bladder Cancer Participants to Nivolumab Monotherapy	Bladder Cancer Patients		23	95% Confidence Interval 14 to 35	percentage of participants with PR/CR
Confirmed Objective Response for Bladder Cancer Patients to Ipilimumab and Nivolumab Combination Therapy in Patients Progressing on Initial Nivolumab Monotherapy	Melanoma Cancer Patients	Partial response + Complete response to ipilimumab and nivolumab combination therapy	0		Participants
Confirmed Objective Response for Bladder Cancer Patients to Ipilimumab and Nivolumab Combination Therapy in Patients Progressing on Initial Nivolumab Monotherapy	Bladder Cancer Patients	Partial response + Complete response to ipilimumab and nivolumab combination therapy	16		Participants
Confirmed Objective Response for Bladder Cancer Patients to Ipilimumab and Nivolumab Combination Therapy in Patients Progressing on Initial Nivolumab Monotherapy	Melanoma Cancer Patients	No Partial response + Complete response to ipilimumab and nivolumab combo therapy	0		Participants
Confirmed Objective Response for Bladder Cancer Patients to Ipilimumab and Nivolumab Combination Therapy in Patients Progressing on Initial Nivolumab Monotherapy	Bladder Cancer Patients	No Partial response + Complete response to ipilimumab and nivolumab combo therapy	53		Participants
Tumor Mutational Burden for Evaluable Bladder Cancer Participants	Bladder Cancer Patients	Median Tumor Mutational Burden/TMB among evaluable bladder participants	502	Full Range 50 to 2255	mut/Mb
Tumor Mutational Burden for Evaluable Bladder Cancer Participants	Bladder Cancer Patients	TMB Missense Only	92	Full Range 4 to 530	mut/Mb

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Melanoma Cancer Patients	10
Overall Study	STARTED	Bladder Cancer Patients	71
Overall Study	COMPLETED	Melanoma Cancer Patients	10
Overall Study	COMPLETED	Bladder Cancer Patients	65
Overall Study	NOT COMPLETED	Melanoma Cancer Patients	0
Overall Study	NOT COMPLETED	Bladder Cancer Patients	6

Source ClinicalTrials.gov

Adverse events196

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	fatigue	General disorders	Melanoma Cancer Patients	10	10
other	fatigue	General disorders	Bladder Cancer Patients	38	69
other	rash maculo-papular	Skin and subcutaneous tissue disorders	Melanoma Cancer Patients	10	10
other	rash maculo-papular	Skin and subcutaneous tissue disorders	Bladder Cancer Patients	31	69
other	Diarrhea	Gastrointestinal disorders	Melanoma Cancer Patients	10	10
other	Diarrhea	Gastrointestinal disorders	Bladder Cancer Patients	36	69
other	pruritus	Skin and subcutaneous tissue disorders	Melanoma Cancer Patients	7	10
other	pruritus	Skin and subcutaneous tissue disorders	Bladder Cancer Patients	24	69
other	nausea	Gastrointestinal disorders	Melanoma Cancer Patients	10	10
other	nausea	Gastrointestinal disorders	Bladder Cancer Patients	20	69

1 to 10 of 196Source ClinicalTrials.gov

See all 196 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Melanoma Cancer Patients	2	10
Total, all-cause mortality	Bladder Cancer Patients	51	69
Total, other adverse events	Melanoma Cancer Patients	10	10
Total, other adverse events	Bladder Cancer Patients	69	69
Total, serious adverse events	Melanoma Cancer Patients	10	10
Total, serious adverse events	Bladder Cancer Patients	69	69

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29489427	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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Melanoma Cancer Patients vs Bladder Cancer Patients: deaths from any cause	Trial comparisons
Melanoma Cancer Patients vs Bladder Cancer Patients: 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.

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/NCT02553642

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API reference For AI assistants