Trial Outcomes & Findings for Phase II Randomized Trial of Ipilimumab Versus Ipilimumab and Radiotherapy in Metastatic Melanoma (NCT NCT01689974)

Results Overview

Eligible patients have metastatic melanoma with at least 2 measurable sites of disease. All patients with metastatic melanoma are eligible to be randomly assigned to Ipilimumab 3mg/kg IV over 90 minutes versus Ipilimumab 3 mg/kg IV over 90 minutes and radiotherapy to one of their measurable lesions, 6 Gy X5 (conformally or by IMRT/IGRT, to maximally spare normal tissue). For patients assigned to the Ipi/RT arm, Ipilimumab treatment starts after radiotherapy, with a dose given on day 4 from the first radiotherapy fraction and repeated on Days 25, 46 and 67. Patients will be re-imaged on Week 12 and evaluated for response (defined as an objective response of another metastatic site outside the radiation field). This response will be evaluated assessing clinical and CT responses in the non-irradiated measurable metastatic sites.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

2 years

Results posted on

2018-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Ipilimumab Ipilimumab administered alone Day 4, 25, 46, and 67 Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67.	Arm B: Ipilimumab and Radiation Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67. Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67.
Overall Study STARTED	5	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Ipilimumab Ipilimumab administered alone Day 4, 25, 46, and 67 Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67.	Arm B: Ipilimumab and Radiation Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67. Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67.
Overall Study Termination of Study	5	5

Baseline Characteristics

Phase II Randomized Trial of Ipilimumab Versus Ipilimumab and Radiotherapy in Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Ipilimumab n=5 Participants Ipilimumab administered alone Day 4, 25, 46, and 67 Ipilimumab: Ipilimumab will be administered alone on day 4, 25, 46 and 67.	Arm B: Ipilimumab and Radiation n=5 Participants Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67. Radiation Therapy and Ipilimumab: Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Study terminated because PI left institution. Data cannot be reported because 2 year data were not collected and were not analyzed.

Eligible patients have metastatic melanoma with at least 2 measurable sites of disease. All patients with metastatic melanoma are eligible to be randomly assigned to Ipilimumab 3mg/kg IV over 90 minutes versus Ipilimumab 3 mg/kg IV over 90 minutes and radiotherapy to one of their measurable lesions, 6 Gy X5 (conformally or by IMRT/IGRT, to maximally spare normal tissue). For patients assigned to the Ipi/RT arm, Ipilimumab treatment starts after radiotherapy, with a dose given on day 4 from the first radiotherapy fraction and repeated on Days 25, 46 and 67. Patients will be re-imaged on Week 12 and evaluated for response (defined as an objective response of another metastatic site outside the radiation field). This response will be evaluated assessing clinical and CT responses in the non-irradiated measurable metastatic sites.

Outcome measures

Outcome data not reported

Adverse Events

Arm A: Ipilimumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B: Ipilimumab and Radiation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sylvia Formenti, MD

New York University School of Medicine

Phone: 646.962.4073

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place