Phase 2
N=146
A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma
Uveal Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT02570308 ↗Enrolled (actual)
146
Serious AEs
35.6%
Results posted
Sep 2021
Primary outcome: Primary: Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1 — 0; 1; 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IMCgp100 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Immunocore Ltd
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1 |
0; 1; 2; 0 | — |
| PRIMARY Objective Response Rate in Phase 2 |
4.7 | — |
| SECONDARY Objective Response Rate in Phase 1 |
15.8 | — |
| SECONDARY Progression-free Survival |
7.4; 2.8 | — |
| SECONDARY Disease Control Rate |
47.4; 22.8 | — |
| SECONDARY Duration of Response |
7.425; 8.706 | — |
| SECONDARY Time to Response |
5.5; 7.0 | — |
| SECONDARY Overall Survival |
29.6; 16.8 | — |
| SECONDARY Minor Response Rate |
26.3; 11.0 | — |
| SECONDARY Number of Participants With Treatment Dose Interruptions or Reductions |
2; 4; 3; 4; 49 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve (AUC) of Tebentafusp |
28550; 36530; 32920; 33030; 81310; 98660 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Tebentafusp |
3050; 3294; 3041; 3640; 8885; 9523 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Tebentafusp |
0.50; 0.50; 0.50; 0.50; 0.50; 0.50 | — |
| SECONDARY Apparent Terminal Plasma Half-life (t½) of Tebentafusp |
6.635; 7.591; 6.442; 6.273; 6.897; 7.532 | — |
| SECONDARY Percentage of Participants With Anti-IMCgp100 Antibody Formation |
66.7; 16.7; 25.0; 33.3; 33.6 | — |
Summary
IMCgp100-102 is a Phase I/II study of the weekly intra-patient escalation dose regimen with IMCgp100 as a single agent in participants with metastatic uveal melanoma (mUM). According to this regimen, all participants in the trial received 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose escalation commenced at the third weekly dose at C1D15. The Phase I testing of the intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter.
Eligibility Criteria
Inclusion Criteria
- Male or female participants age ≥ 18 years of age at the time of informed consent.
- Ability to provide and understand written informed consent prior to any study procedures.
- Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma (mUM).
- Surgically sterile participants or participants of child-bearing potential who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug.
- Human leukocyte antigen (HLA)-A*0201 positive.
- ECOG Performance Status of 0 or 1 at Screening.
- Phase 2 will include participants with previously treated uveal melanoma in the metastatic setting.
Exclusion Criteria
- Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids.
- History of severe hypersensitivity reactions to other biologic drugs or monoclonal antibodies.
- Participants with any out-of-range laboratory values.
- Clinically significant cardiac disease or impaired cardiac function.
- Active infection requiring systemic antibiotic therapy.
- Known history of HIV infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol.
- Participants receiving systemic treatment with systemic steroid therapy or any other immunosuppressive medication at any dose level that would interfere with the action of the study drugs in the opinion of the investigator.
- Malignant disease, other than that being treated in this study.
- Any medical condition that would, in the investigator's judgment, prevent participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
- Presence of NCI CTCAE ≥ grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ NCI CTCAE grade 3) due to prior cancer therapy.
- Pregnant, likely to become pregnant, or lactating women.
Data sourced from ClinicalTrials.gov (NCT02570308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.