Trial Outcomes & Findings for 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 NCT02553642)
NCT ID: NCT02553642
Last Updated: 2025-07-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
From treatment start, up to 2 years from initial dose of nivolumab.
Results posted on
2025-07-22
Participant Flow
Participant milestones
| Measure |
Melanoma Cancer Patients
All eligible patients with melanoma will receive ipilimumab at a dose of 3 mg/kg combined with nivolumab at a dose of 1 mg/kg. The ipilimumab and nivolumab will be dosed every 3 weeks for 4 doses. Thereafter, patients may be eligible to continue to receive nivolumab monotherapy at a dose of 240 mg administered every 2 weeks OR nivolumab at dose of 480mg every 4 weeks for up to 2 years.
Nivolumab plus Ipilimumab: Combination Treatment
* Ipilimumab 3 mg/kg
* Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses
|
Bladder Cancer Patients
All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years. All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years.
Nivolumab: Monotherapy Treatment - Nivolumab 240 mg flat dose Dosed q 2 weeks
OR
\- Nivolumab 480 mg flat dose Dosed q 4 weeks
for up to 2 years from 1st dose of nivolumab or until loss of clinical benefit
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
71
|
|
Overall Study
COMPLETED
|
10
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
Melanoma Cancer Patients
All eligible patients with melanoma will receive ipilimumab at a dose of 3 mg/kg combined with nivolumab at a dose of 1 mg/kg. The ipilimumab and nivolumab will be dosed every 3 weeks for 4 doses. Thereafter, patients may be eligible to continue to receive nivolumab monotherapy at a dose of 240 mg administered every 2 weeks OR nivolumab at dose of 480mg every 4 weeks for up to 2 years.
Nivolumab plus Ipilimumab: Combination Treatment
* Ipilimumab 3 mg/kg
* Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses
|
Bladder Cancer Patients
All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years. All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years.
Nivolumab: Monotherapy Treatment - Nivolumab 240 mg flat dose Dosed q 2 weeks
OR
\- Nivolumab 480 mg flat dose Dosed q 4 weeks
for up to 2 years from 1st dose of nivolumab or until loss of clinical benefit
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Additional cancer dx
|
0
|
1
|
|
Overall Study
Never started treatment
|
0
|
1
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Melanoma Cancer Patients
n=10 Participants
All eligible patients with melanoma will receive ipilimumab at a dose of 3 mg/kg combined with nivolumab at a dose of 1 mg/kg. The ipilimumab and nivolumab will be dosed every 3 weeks for 4 doses. Thereafter, patients may be eligible to continue to receive nivolumab monotherapy at a dose of 240 mg administered every 2 weeks OR nivolumab at dose of 480mg every 4 weeks for up to 2 years.
Nivolumab plus Ipilimumab: Combination Treatment
* Ipilimumab 3 mg/kg
* Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses
|
Bladder Cancer Patients
n=69 Participants
All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years. All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years.
Nivolumab: Monotherapy Treatment - Nivolumab 240 mg flat dose Dosed q 2 weeks
OR
\- Nivolumab 480 mg flat dose Dosed q 4 weeks
for up to 2 years from 1st dose of nivolumab or until loss of clinical benefit
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
68 years
n=107 Participants
|
67 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From treatment start, up to 2 years from initial dose of nivolumab.Population: Only Bladder Cancer Patients were evaluated
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.
Outcome measures
| Measure |
Melanoma Cancer Patients
All eligible patients with melanoma will receive ipilimumab at a dose of 3 mg/kg combined with nivolumab at a dose of 1 mg/kg. The ipilimumab and nivolumab will be dosed every 3 weeks for 4 doses. Thereafter, patients may be eligible to continue to receive nivolumab monotherapy at a dose of 240 mg administered every 2 weeks OR nivolumab at dose of 480mg every 4 weeks for up to 2 years.
Nivolumab plus Ipilimumab: Combination Treatment
* Ipilimumab 3 mg/kg
* Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses
|
Bladder Cancer Patients
n=69 Participants
All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years. All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years.
Nivolumab: Monotherapy Treatment - Nivolumab 240 mg flat dose Dosed q 2 weeks
OR
\- Nivolumab 480 mg flat dose Dosed q 4 weeks
for up to 2 years from 1st dose of nivolumab or until loss of clinical benefit
|
|---|---|---|
|
Confirmed Objective Response in Bladder Cancer Participants to Nivolumab Monotherapy
|
—
|
23 percentage of participants with PR/CR
Interval 14.0 to 35.0
|
PRIMARY outcome
Timeframe: From treatment start, up to 2 years from initial dose of nivolumab.Population: Only Bladder Cancer Participants were evaluated
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.
Outcome measures
| Measure |
Melanoma Cancer Patients
All eligible patients with melanoma will receive ipilimumab at a dose of 3 mg/kg combined with nivolumab at a dose of 1 mg/kg. The ipilimumab and nivolumab will be dosed every 3 weeks for 4 doses. Thereafter, patients may be eligible to continue to receive nivolumab monotherapy at a dose of 240 mg administered every 2 weeks OR nivolumab at dose of 480mg every 4 weeks for up to 2 years.
Nivolumab plus Ipilimumab: Combination Treatment
* Ipilimumab 3 mg/kg
* Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses
|
Bladder Cancer Patients
n=69 Participants
All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years. All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years.
Nivolumab: Monotherapy Treatment - Nivolumab 240 mg flat dose Dosed q 2 weeks
OR
\- Nivolumab 480 mg flat dose Dosed q 4 weeks
for up to 2 years from 1st dose of nivolumab or until loss of clinical benefit
|
|---|---|---|
|
Confirmed Objective Response for Bladder Cancer Patients to Ipilimumab and Nivolumab Combination Therapy in Patients Progressing on Initial Nivolumab Monotherapy
No Partial response + Complete response to ipilimumab and nivolumab combo therapy
|
0 Participants
|
53 Participants
|
|
Confirmed Objective Response for Bladder Cancer Patients to Ipilimumab and Nivolumab Combination Therapy in Patients Progressing on Initial Nivolumab Monotherapy
Partial response + Complete response to ipilimumab and nivolumab combination therapy
|
0 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: At baselinePopulation: Evaluable bladder cancer patients were analyzed
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.
Outcome measures
| Measure |
Melanoma Cancer Patients
All eligible patients with melanoma will receive ipilimumab at a dose of 3 mg/kg combined with nivolumab at a dose of 1 mg/kg. The ipilimumab and nivolumab will be dosed every 3 weeks for 4 doses. Thereafter, patients may be eligible to continue to receive nivolumab monotherapy at a dose of 240 mg administered every 2 weeks OR nivolumab at dose of 480mg every 4 weeks for up to 2 years.
Nivolumab plus Ipilimumab: Combination Treatment
* Ipilimumab 3 mg/kg
* Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses
|
Bladder Cancer Patients
n=63 Participants
All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years. All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years.
Nivolumab: Monotherapy Treatment - Nivolumab 240 mg flat dose Dosed q 2 weeks
OR
\- Nivolumab 480 mg flat dose Dosed q 4 weeks
for up to 2 years from 1st dose of nivolumab or until loss of clinical benefit
|
|---|---|---|
|
Tumor Mutational Burden for Evaluable Bladder Cancer Participants
Median Tumor Mutational Burden/TMB among evaluable bladder participants
|
—
|
502 mut/Mb
Interval 50.0 to 2255.0
|
|
Tumor Mutational Burden for Evaluable Bladder Cancer Participants
TMB Missense Only
|
—
|
92 mut/Mb
Interval 4.0 to 530.0
|
Adverse Events
Melanoma Cancer Patients
Serious events: 10 serious events
Other events: 10 other events
Deaths: 2 deaths
Bladder Cancer Patients
Serious events: 69 serious events
Other events: 69 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
Melanoma Cancer Patients
n=10 participants at risk
All eligible patients with melanoma will receive ipilimumab at a dose of 3 mg/kg combined with nivolumab at a dose of 1 mg/kg. The ipilimumab and nivolumab will be dosed every 3 weeks for 4 doses. Thereafter, patients may be eligible to continue to receive nivolumab monotherapy at a dose of 240 mg administered every 2 weeks OR nivolumab at dose of 480mg every 4 weeks for up to 2 years.
Nivolumab plus Ipilimumab: Combination Treatment
* Ipilimumab 3 mg/kg
* Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses
|
Bladder Cancer Patients
n=69 participants at risk
All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years. All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years.
Nivolumab: Monotherapy Treatment - Nivolumab 240 mg flat dose Dosed q 2 weeks
OR
\- Nivolumab 480 mg flat dose Dosed q 4 weeks
for up to 2 years from 1st dose of nivolumab or until loss of clinical benefit
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
4/10 • 2 years
|
13.0%
9/69 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
20.0%
2/10 • 2 years
|
0.00%
0/69 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms
|
10.0%
1/10 • 2 years
|
4.3%
3/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediastinal disorder
|
10.0%
1/10 • 2 years
|
0.00%
0/69 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
1/10 • 2 years
|
0.00%
0/69 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
10.0%
1/10 • 2 years
|
0.00%
0/69 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • 2 years
|
0.00%
0/69 • 2 years
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
General disorders
Death NOS
|
0.00%
0/10 • 2 years
|
17.4%
12/69 • 2 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/10 • 2 years
|
5.8%
4/69 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • 2 years
|
5.8%
4/69 • 2 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • 2 years
|
5.8%
4/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/10 • 2 years
|
5.8%
4/69 • 2 years
|
|
General disorders
Fatigue
|
0.00%
0/10 • 2 years
|
5.8%
4/69 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • 2 years
|
5.8%
4/69 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • 2 years
|
5.8%
4/69 • 2 years
|
|
Infections and infestations
Bladder Infection
|
0.00%
0/10 • 2 years
|
4.3%
3/69 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/10 • 2 years
|
4.3%
3/69 • 2 years
|
|
Investigations
Increased Alt
|
0.00%
0/10 • 2 years
|
4.3%
3/69 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • 2 years
|
2.9%
2/69 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/10 • 2 years
|
2.9%
2/69 • 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/10 • 2 years
|
2.9%
2/69 • 2 years
|
|
Investigations
Increased Ast
|
0.00%
0/10 • 2 years
|
2.9%
2/69 • 2 years
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/10 • 2 years
|
2.9%
2/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/10 • 2 years
|
2.9%
2/69 • 2 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • 2 years
|
2.9%
2/69 • 2 years
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/10 • 2 years
|
2.9%
2/69 • 2 years
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Renal and urinary disorders
Bladder Flank Spams Bladder Burning
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Gastrointestinal disorders
Colonic Perforation
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
General disorders
Fever
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Infections and infestations
Infections and Infestations Other Specify Cellulitis
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Infections and infestations
Lung Infection
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Infections and infestations
Pelvic Infection
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Vascular disorders
Vasculitis
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
|
Investigations
Weight Loss
|
0.00%
0/10 • 2 years
|
1.4%
1/69 • 2 years
|
Other adverse events
| Measure |
Melanoma Cancer Patients
n=10 participants at risk
All eligible patients with melanoma will receive ipilimumab at a dose of 3 mg/kg combined with nivolumab at a dose of 1 mg/kg. The ipilimumab and nivolumab will be dosed every 3 weeks for 4 doses. Thereafter, patients may be eligible to continue to receive nivolumab monotherapy at a dose of 240 mg administered every 2 weeks OR nivolumab at dose of 480mg every 4 weeks for up to 2 years.
Nivolumab plus Ipilimumab: Combination Treatment
* Ipilimumab 3 mg/kg
* Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses
|
Bladder Cancer Patients
n=69 participants at risk
All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years. All eligible patients with bladder cancer will receive nivolumab at a dose of 240 mg administered every 2 weeks for up to 2 years, if the patient is clinically benefitting, the PI and treating investigator may elect to continue treatment beyond 2 years.
Nivolumab: Monotherapy Treatment - Nivolumab 240 mg flat dose Dosed q 2 weeks
OR
\- Nivolumab 480 mg flat dose Dosed q 4 weeks
for up to 2 years from 1st dose of nivolumab or until loss of clinical benefit
|
|---|---|---|
|
General disorders
fatigue
|
100.0%
10/10 • 2 years
|
55.1%
38/69 • 2 years
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
100.0%
10/10 • 2 years
|
44.9%
31/69 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
10/10 • 2 years
|
52.2%
36/69 • 2 years
|
|
Skin and subcutaneous tissue disorders
pruritus
|
70.0%
7/10 • 2 years
|
34.8%
24/69 • 2 years
|
|
Gastrointestinal disorders
nausea
|
100.0%
10/10 • 2 years
|
29.0%
20/69 • 2 years
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/10 • 2 years
|
21.7%
15/69 • 2 years
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
40.0%
4/10 • 2 years
|
20.3%
14/69 • 2 years
|
|
Metabolism and nutrition disorders
anorexia
|
30.0%
3/10 • 2 years
|
23.2%
16/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
100.0%
10/10 • 2 years
|
18.8%
13/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
30.0%
3/10 • 2 years
|
18.8%
13/69 • 2 years
|
|
General disorders
edema limbs
|
0.00%
0/10 • 2 years
|
14.5%
10/69 • 2 years
|
|
Endocrine disorders
hypothyroidism
|
40.0%
4/10 • 2 years
|
13.0%
9/69 • 2 years
|
|
Investigations
increased alt
|
100.0%
10/10 • 2 years
|
14.5%
10/69 • 2 years
|
|
Gastrointestinal disorders
dry mouth
|
20.0%
2/10 • 2 years
|
14.5%
10/69 • 2 years
|
|
Investigations
increased ast
|
50.0%
5/10 • 2 years
|
10.1%
7/69 • 2 years
|
|
Gastrointestinal disorders
abdominal pain
|
60.0%
6/10 • 2 years
|
7.2%
5/69 • 2 years
|
|
General disorders
fever
|
50.0%
5/10 • 2 years
|
8.7%
6/69 • 2 years
|
|
Vascular disorders
hot flashes/night sweats
|
0.00%
0/10 • 2 years
|
7.2%
5/69 • 2 years
|
|
Gastrointestinal disorders
mucositis oral
|
0.00%
0/10 • 2 years
|
8.7%
6/69 • 2 years
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/10 • 2 years
|
7.2%
5/69 • 2 years
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/10 • 2 years
|
7.2%
5/69 • 2 years
|
|
Nervous system disorders
headache
|
0.00%
0/10 • 2 years
|
5.8%
4/69 • 2 years
|
|
Injury, poisoning and procedural complications
infusion related reaction
|
10.0%
1/10 • 2 years
|
5.8%
4/69 • 2 years
|
|
General disorders
pain
|
0.00%
0/10 • 2 years
|
7.2%
5/69 • 2 years
|
|
Nervous system disorders
peripheral sensory neuropathy
|
0.00%
0/10 • 2 years
|
5.8%
4/69 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
0.00%
0/10 • 2 years
|
10.1%
7/69 • 2 years
|
|
Gastrointestinal disorders
vomiting
|
50.0%
5/10 • 2 years
|
2.9%
2/69 • 2 years
|
|
General disorders
chills
|
0.00%
0/10 • 2 years
|
8.7%
6/69 • 2 years
|
|
Skin and subcutaneous tissue disorders
dry skin
|
10.0%
1/10 • 2 years
|
5.8%
4/69 • 2 years
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
30.0%
3/10 • 2 years
|
4.3%
3/69 • 2 years
|
|
Endocrine disorders
adrenal insufficiency
|
30.0%
3/10 • 2 years
|
2.9%
2/69 • 2 years
|
|
Gastrointestinal disorders
colitis
|
10.0%
1/10 • 2 years
|
4.3%
3/69 • 2 years
|
|
Investigations
Weight loss
|
20.0%
2/10 • 2 years
|
0.00%
0/69 • 2 years
|
Additional Information
Dr. Samuel Funt, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4718
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place