| 1 |
NCT02889861 |
Recruiting |
IMCgp100-401 Rollover Study |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events
- Tolerability: Dose interruptions, reductions, and dose intensity of IMCgp100
- Assessments of anti-IMCgp100 antibody formation
- Date of death in all patients treated with IMCgp100
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT02889861 |
IMCgp100-401 |
|
January 18, 2017 |
July 2020 |
August 2020 |
September 7, 2016 |
July 26, 2018 |
|
- Memorial Slone Kettering Cancer Center
New York, New York, United States - Dept of Oncology & Haematology, Churchill Hospital
Oxford, Oxfordshire, United Kingdom - Dept of Medical Oncology, Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
|
|
| 2 |
NCT03070392 |
Recruiting |
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma |
|
- Biological: IMCgp100
- Drug: Dacarbazine
- Biological: Ipilimumab
- Biological: Pembrolizumab
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival defined as the time from patient inclusion to date of death due to any cause
- Safety defined as the number of patients with treatment emergent adverse events, laboratory abnormalities, ECG changes, and/or physical examination findings
- Efficacy: Objective response rate (ORR) defined as the proportion of patients achieving an objective response (RECIST v1.1) by Independent Central Review
- (and 10 more...)
|
327 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT03070392 |
IMCgp100-202 |
|
October 16, 2017 |
July 2020 |
March 2023 |
March 3, 2017 |
October 11, 2018 |
|
- UCLA Medical Center
Los Angeles, California, United States - The Angeles Clinic and Research Institute
Los Angeles, California, United States - Byers Eye Institute, Stanford University
Palo Alto, California, United States - (and 32 more...)
|
|
| 3 |
NCT01211262 |
Completed |
Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma |
|
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Definition of the maximum tolerated dose (MTD) and evaluation of the safety and tolerability of multiple injections of IMCgp100 for each of two treatment regimens (weekly dosing and daily dosing)
- Characterisation of the pharmacokinetics and changes in tumour burden following IMCgp100 administration
|
84 |
All |
18 Years and older (Adult, Older Adult) |
NCT01211262 |
IMCgp100/01
2010-019290-15 |
|
September 28, 2010 |
February 16, 2016 |
February 16, 2017 |
September 29, 2010 |
March 24, 2017 |
|
- The Angeles Clinic
Los Angeles, California, United States - Yale Cancer Center
New Haven, Connecticut, United States - Memorial Slone Kettering Cancer Center
New York, New York, United States - (and 6 more...)
|
|
| 4 |
NCT01209676 |
Completed |
IMCgp100 in Advanced Unresectable Melanoma |
- Melanoma
- Advanced Disease
- Unresectable
|
|
Interventional
|
Early Phase 1 |
- University of Pennsylvania
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse Events as a Measure of Safety and Tolerability
- Adverse events
- Vital signs
- (and 2 more...)
|
1 |
All |
18 Years and older (Adult, Older Adult) |
NCT01209676 |
UPCC 03610 |
|
September 2010 |
March 2013 |
|
September 27, 2010 |
November 15, 2016 |
|
- Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
|
| 5 |
NCT02570308 |
Recruiting |
A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma |
|
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase 1 Recommended phase 2 dose of the intra-patient escalation regimen (RP2D-IE)
- 2. Phase 2: Objective response rate by RECIST 1.1 assessed by independent central review
- Objective response rate (Phase 1)
- (and 11 more...)
|
150 |
All |
18 Years and older (Adult, Older Adult) |
NCT02570308 |
IMCgp100-102 |
|
February 2016 |
September 2019 |
|
October 7, 2015 |
October 11, 2018 |
|
- University California, San Diego Moores Cancer Center
La Jolla, California, United States - The Angeles Clinic and Research Institute - W LA Office
Los Angeles, California, United States - University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States - (and 18 more...)
|
|
| 6 |
NCT02535078 |
Recruiting |
Phase 1b/2 Study of the Combination of IMCgp100 With Durvalumab and/or Tremelimumab in Cutaneous Melanoma |
|
- Drug: IMCgp100
- Drug: durvalumab
- Drug: tremelimumab
|
Interventional
|
Phase 1
Phase 2 |
- Immunocore Ltd
- MedImmune LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival
- Objective response rate
- Overall survival
|
225 |
All |
18 Years and older (Adult, Older Adult) |
NCT02535078 |
IMCgp100-201 |
|
November 2015 |
November 2018 |
November 2019 |
August 28, 2015 |
July 25, 2018 |
|
- The Angeles Clinic and Research Institute
Los Angeles, California, United States - University of California, Los Angeles
Los Angeles, California, United States - University of Colorado Cancer Center
Aurora, Colorado, United States - (and 21 more...)
|
|
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