Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
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|ClinicalTrials.gov Identifier: NCT03070392|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Results First Posted : September 14, 2021
Last Update Posted : March 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Uveal Melanoma||Biological: IMCgp100 Drug: Dacarbazine Biological: Ipilimumab Biological: Pembrolizumab||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||378 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma|
|Actual Study Start Date :||October 16, 2017|
|Actual Primary Completion Date :||October 13, 2020|
|Estimated Study Completion Date :||March 2023|
Experimental: IMCgp100 (tebentafusp, Kimmtrak)
Biologic:IMCgp100 (Soluble gp 100-specific T cell receptor with anti - CD3 scFV: IMCgp100)
IMCgp100 is to be administered at 20 mcg cycle 1 day1, then 30 mcg cycle 1 day 8, then 68 mcg cycle 1 day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity
Active Comparator: Investigator's Choice
1 of 3 Investigator's Choice options: Systemic Dacarbazine
1 of 3 Investigator's Choice options: Systemic Ipilimumab
1 of 3 Investigator's Choice options: Systemic Pembrolizumab
Dacarbazine is to be administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity
Ipilimumab is to be administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments
Other Name: Yervoy
Pembrolizumab is to be administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity
Other Name: Keytruda
- Efficacy: Overall Survival [ Time Frame: From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months. ]Overall survival is defined as the time from randomization to date of death due to any cause.
- Safety: Number of Participants With Treatment Emergent Adverse Events [ Time Frame: Safety was assessed from informed consent through 90 days after end of treatment, up to 36 months. ]Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings.
- Efficacy: Progression Free Survival (PFS) [ Time Frame: PFS was assessed every 3 months from randomization until disease progression or death, up to 36 months. ]Progression free survival (PFS) is defined as the time from randomization to the date of progression (RECIST v1.1) or death due to any cause.
- Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores [ Time Frame: EQ-5D,5L was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. ]General health status was assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse health state. A positive change indicates improvement.
- Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) [ Time Frame: EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. ]The EQ-5D VAS score records the participant's self-rated health on a vertical visual analogue scale, with 0 being the worst imaginable health state and 100 being the best imaginable health state. A positive change indicates improvement.
- Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status [ Time Frame: EORTC QLQ-C30 was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. ]Global health status and quality of life was assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. A positive change indicates improvement.
- Pharmacokinetics (PK): Tebentafusp Concentration [ Time Frame: PK concentrations were assessed at pre-dose, end of infusion and anytime in the 12 to 24 hour window after completion of the infusion in Cycle 1 on Days 1, 8 and 15. ]Serum PK concentrations of tebentafusp were collected over time.
- Efficacy: Objective Response Rate (ORR) [ Time Frame: ORR will be assessed after every participant has had at least 3 assessments, conducted every 3 months, up to 5.5 years. ]Objective response rate (ORR) is defined as the proportion of patients achieving an objective response (RECIST v1.1).
- Efficacy: Duration of Response (DOR) [ Time Frame: DOR will be assessed every 3 months from randomization until disease progression, assessed up to 5.5 years. ]Duration of response (DOR) is defined as the time from first documented objective response (RECIST v1.1) until the date of documented disease progression.
- Efficacy: Disease Control Rate (DCR) [ Time Frame: DCR will be assessed every 3 months from randomization until disease progression, up to 5.5 years. ]Disease control rate (DCR) is defined as the proportion of patients with either an objective response or stable disease (RECIST v1.1)
- Pharmacokinetics: Frequency of Anti-IMCgp100 Antibody Formation [ Time Frame: Approximately 5 assessments will be performed between first dose of IMCgp100 and end of treatment, assessed up to 5.5 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070392
|Study Director:||Mohammed Dar||Immunocore Ltd|