A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma
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| ClinicalTrials.gov Identifier: NCT02570308 |
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Recruitment Status :
Active, not recruiting
First Posted : October 7, 2015
Last Update Posted : April 9, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uveal Melanoma | Drug: IMCgp100 | Phase 1 Phase 2 |
This is a Phase I/II clinical study of IMCgp100 in patients with advanced uveal melanoma.
This is a Phase I/II study of IMCgp100 administered on a weekly basis with an intra-patient escalation dosing regimen. The intra-patient escalation occurs at the third weekly dose on Cycle 1 Day 15 (C1D15). According to this regimen, all patients in the trial will receive 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose escalation will commence at the third weekly dose at C1D15 with the goal to achieve a long-term dosing regimen at a dose higher than that identified for the straight weekly dosing regimen (RP2D-QW). The dose escalation will identify the intra-patient escalation regimen (RP2D-IE).
The Phase I portion of the study was a standard 3+3 dose escalation design. The Phase 1 portion of the study is now complete. The recommended Phase II dose of the intra-patient escalation dose regimen (RP2D-IE) was identified and the 2 expansion cohorts in metastatic uveal melanoma will be completed. The cohorts will enroll patients with metastatic uveal melanoma and are defined based on prior therapy The expansion portion will enroll approximately 150 patients.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Using the Intra-patient Escalation Dosing Regimen in Patients With Advanced Uveal Melanoma |
| Study Start Date : | February 2016 |
| Actual Primary Completion Date : | June 30, 2020 |
| Estimated Study Completion Date : | September 20, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dose escalation
Dose escalation cohorts of the intra-patient escalation regimen. This arm is closed
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Drug: IMCgp100
Bispecific soluble HLA-A2 restricted gp100-specific TCR fused to anti-CD3 |
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Experimental: Dose expansion
Dose expansion cohort with the recommended phase 2 dose of the intra-patient dose escalation regimen
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Drug: IMCgp100
Bispecific soluble HLA-A2 restricted gp100-specific TCR fused to anti-CD3 |
- Phase 1 Recommended phase 2 dose of the intra-patient escalation regimen (RP2D-IE) [ Time Frame: 1 years ]
- 2. Phase 2: Objective response rate by RECIST 1.1 assessed by independent central review [ Time Frame: 2 years ]
- Objective response rate (Phase 1) [ Time Frame: 2 years ]
- Progression free survival [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 2 years ]
- Duration of response [ Time Frame: 2 years ]
- Time to response [ Time Frame: 2 years ]
- Minor response rate [ Time Frame: 2 years ]
- Number of treatment dose interruptions and reductions [ Time Frame: 2 years ]
- Area under the plasma concentration-time curve (AUC) [ Time Frame: 2 years ]
- Area under the plasma concentration-time curve (AUC) [ Time Frame: 3 weeks ]
- The maximum observed plasma drug concentration after single dose administration (Cmax) [ Time Frame: 2 years ]
- The time to reach maximum plasma concentration (Tmax) [ Time Frame: 3 weeks ]
- The elimination half-life (t1/2) [ Time Frame: 3 weeks ]
- Incidence of anti-IMCgp100 antibody formation [ Time Frame: 2 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female patients 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 patients or patients 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
- Patients in Phase 2 will include patients 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
- Patient 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.
- Patients 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 the patient's 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.
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): NCT02570308
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| Responsible Party: | Immunocore Ltd |
| ClinicalTrials.gov Identifier: | NCT02570308 |
| Other Study ID Numbers: |
IMCgp100-102 |
| First Posted: | October 7, 2015 Key Record Dates |
| Last Update Posted: | April 9, 2021 |
| Last Verified: | April 2021 |
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Tebentafusp IMCgp100 gp100 metastatic melanoma ImmTAC Immunotherapy |
Bispecific T cell receptor fusion protein Immune mobilizing monoclonal T cell receptor against cancer UM mUM |
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Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases |