Trial Outcomes & Findings for High-Dose Aldesleukin and Ipilimumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed By Surgery (NCT NCT02203604)

NCT ID: NCT02203604

Last Updated: 2023-07-18

Results Overview

Defined as the ratio of the number of participants whose number of participants whose best response is a complete response or partial response. 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.", or similar definition that is accurate and appropriate.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Up to 24 weeks

Results posted on

2023-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Aldesleukin, Ipilimumab) INDUCTION: Patients receive ipilimumab IV over 90 minutes on days 1, 22, 43, and 64 and high-dose aldesleukin IV on days 22-26 and 43-47. MAINTENANCE: Beginning on weeks 24, patients without disease progression or unacceptable toxicity receive ipilimumab IV over 90 minutes once every 12 weeks for up to 24 weeks in the absence of disease progression or unacceptable toxicity. aldesleukin: Given IV ipilimumab: Given IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High-Dose Aldesleukin and Ipilimumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Aldesleukin, Ipilimumab) n=9 Participants INDUCTION: Patients receive ipilimumab IV over 90 minutes on days 1, 22, 43, and 64 and high-dose aldesleukin IV on days 22-26 and 43-47. MAINTENANCE: Beginning on weeks 24, patients without disease progression or unacceptable toxicity receive ipilimumab IV over 90 minutes once every 12 weeks for up to 24 weeks in the absence of disease progression or unacceptable toxicity. aldesleukin: Given IV ipilimumab: Given IV laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Outcome measures

Outcome measures
Measure	Objective Response Rate as Determined by mWHO Criteria n=9 Participants Defined as the ratio of the number of participants whose number of participants whose best response is a complete response or partial response. 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. Up to 24 weeks
Objective Response Rate as Determined by mWHO Criteria	1 Participants

SECONDARY outcome

Timeframe: Up to 60 weeks

The number of participants with adverse in each classification of severity and relationship to treatment will be reported.

Outcome measures

Outcome measures
Measure	Objective Response Rate as Determined by mWHO Criteria n=9 Participants Defined as the ratio of the number of participants whose number of participants whose best response is a complete response or partial response. 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. Up to 24 weeks
Number of Participants With Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	7 participants

SECONDARY outcome

Timeframe: Time from the date of registration to the date of death from any cause, assessed up to 3 years

number of until death from any cause after the start of treatment

Outcome measures

Outcome measures
Measure	Objective Response Rate as Determined by mWHO Criteria n=9 Participants Defined as the ratio of the number of participants whose number of participants whose best response is a complete response or partial response. 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. Up to 24 weeks
Overall Survival	5 Participants

SECONDARY outcome

Timeframe: Time from the date of registration until the date of documented disease progression or death, assessed up to up to 104 weeks

Count of participants from the date of diagnosis or the start of treatment.

Outcome measures

Outcome measures
Measure	Objective Response Rate as Determined by mWHO Criteria n=9 Participants Defined as the ratio of the number of participants whose number of participants whose best response is a complete response or partial response. 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. Up to 24 weeks
Count of Participants With Increased Effector CD8+ T Cells	4 Participants

SECONDARY outcome

Timeframe: After the first 24 weeks

Best overall response was defined as participants who achieved a complete or partial overall response as assessed by the Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions

Outcome measures

Outcome measures
Measure	Objective Response Rate as Determined by mWHO Criteria n=9 Participants Defined as the ratio of the number of participants whose number of participants whose best response is a complete response or partial response. 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. Up to 24 weeks
Best Overall Response, Defined as the Best Response Across All Time Points	1 Participants

SECONDARY outcome

Timeframe: Up to 104 weeks

Population: Data was not collected.

Treatment effect for each patient will be measured as paired differences between pre and post measurements of these parameters at various times. Transformation of the data will be performed if appropriate, e.g. log transformation, and hence treatment effect will be expressed on a log scale. Data relating to immune response will be presented as descriptive summary statistics (such as mean, standard error and 90% confidence intervals \[CI\]). The purity of the CD8+ T cells can then be measured via flow cytometry next the cells are counted and categorized.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 104 weeks

Population: Data was not collected.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Aldesleukin, Ipilimumab)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Aldesleukin, Ipilimumab) n=9 participants at risk INDUCTION: Patients receive ipilimumab IV over 90 minutes on days 1, 22, 43, and 64 and high-dose aldesleukin IV on days 22-26 and 43-47. MAINTENANCE: Beginning on weeks 24, patients without disease progression or unacceptable toxicity receive ipilimumab IV over 90 minutes once every 12 weeks for up to 24 weeks in the absence of disease progression or unacceptable toxicity. aldesleukin: Given IV ipilimumab: Given IV laboratory biomarker analysis: Correlative studies
Cardiac disorders Atrial fibrillation	11.1% 1/9 • Number of events 1 • Adverse events were collected over a period of three years.
Infections and infestations Skin infection	11.1% 1/9 • Number of events 1 • Adverse events were collected over a period of three years.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 1/9 • Number of events 1 • Adverse events were collected over a period of three years.
Renal and urinary disorders Acute kidney injury	11.1% 1/9 • Number of events 1 • Adverse events were collected over a period of three years.

Other adverse events

Other adverse events
Measure	Treatment (Aldesleukin, Ipilimumab) n=9 participants at risk INDUCTION: Patients receive ipilimumab IV over 90 minutes on days 1, 22, 43, and 64 and high-dose aldesleukin IV on days 22-26 and 43-47. MAINTENANCE: Beginning on weeks 24, patients without disease progression or unacceptable toxicity receive ipilimumab IV over 90 minutes once every 12 weeks for up to 24 weeks in the absence of disease progression or unacceptable toxicity. aldesleukin: Given IV ipilimumab: Given IV laboratory biomarker analysis: Correlative studies
General disorders Fatigue	22.2% 2/9 • Adverse events were collected over a period of three years.
General disorders Fever	22.2% 2/9 • Adverse events were collected over a period of three years.
General disorders Chills	11.1% 1/9 • Adverse events were collected over a period of three years.
General disorders Infusion related reaction	11.1% 1/9 • Adverse events were collected over a period of three years.
General disorders Localized edema	11.1% 1/9 • Adverse events were collected over a period of three years.
Gastrointestinal disorders Pain	11.1% 1/9 • Adverse events were collected over a period of three years.
Gastrointestinal disorders Abdominal pain	22.2% 2/9 • Adverse events were collected over a period of three years.
Gastrointestinal disorders Gastric ulcer	11.1% 1/9 • Adverse events were collected over a period of three years.
Gastrointestinal disorders Gastrointestinal pain	11.1% 1/9 • Number of events 1 • Adverse events were collected over a period of three years.
Gastrointestinal disorders Nausea	11.1% 1/9 • Adverse events were collected over a period of three years.
Gastrointestinal disorders Vomiting	11.1% 1/9 • Adverse events were collected over a period of three years.
Skin and subcutaneous tissue disorders Erythroderma	11.1% 1/9 • Adverse events were collected over a period of three years.
Skin and subcutaneous tissue disorders Hyperhidrosis	11.1% 1/9 • Adverse events were collected over a period of three years.
Skin and subcutaneous tissue disorders Periorbital edema	11.1% 1/9 • Adverse events were collected over a period of three years.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.1% 1/9 • Adverse events were collected over a period of three years.
Infections and infestations Rash pustular	11.1% 1/9 • Adverse events were collected over a period of three years.
Infections and infestations Sinusitis	11.1% 1/9 • Adverse events were collected over a period of three years.
Metabolism and nutrition disorders Anorexia	11.1% 1/9 • Adverse events were collected over a period of three years.
Metabolism and nutrition disorders Hyperkalemia	11.1% 1/9 • Adverse events were collected over a period of three years.
Vascular disorders Hypotension	11.1% 1/9 • Adverse events were collected over a period of three years.
Vascular disorders Lymphedema	11.1% 1/9 • Adverse events were collected over a period of three years.
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Adverse events were collected over a period of three years.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	11.1% 1/9 • Adverse events were collected over a period of three years.
Cardiac disorders Palpitations	11.1% 1/9 • Adverse events were collected over a period of three years.
Ear and labyrinth disorders External ear inflammation	11.1% 1/9 • Adverse events were collected over a period of three years.
Endocrine disorders Hypothyroidism	11.1% 1/9 • Adverse events were collected over a period of three years.
Eye disorders Scleral disorder	11.1% 1/9 • Adverse events were collected over a period of three years.
Musculoskeletal and connective tissue disorders Neck pain	11.1% 1/9 • Adverse events were collected over a period of three years.
Nervous system disorders Dysgeusia	11.1% 1/9 • Adverse events were collected over a period of three years.
Psychiatric disorders Anxiety	11.1% 1/9 • Adverse events were collected over a period of three years.
Renal and urinary disorders Acute kidney injury	11.1% 1/9 • Adverse events were collected over a period of three years.
Reproductive system and breast disorders Pelvic pain	11.1% 1/9 • Adverse events were collected over a period of three years.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 1/9 • Adverse events were collected over a period of three years.

Additional Information

Ann Silk, MD

Dana Farber Cancer Institute

Phone: 617-632-6571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place