A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma

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Brief Title

A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma

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

Brief 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.
    

Detailed Description

      This is a Phase I/II clinical study of IMCgp100 in participants 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 occurred at the third weekly dose on
      Cycle 1 Day 15 (C1D15). 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 with
      the goal to achieve a long-term dosing regimen at a dose higher than that identified for the
      weekly dosing regimen (RP2D-QW). The dose escalation identified the intra-patient escalation
      regimen (RP2D-IE).

      The Phase I portion of the study was a standard 3+3 dose escalation design.The recommended
      Phase II dose of the intra-patient escalation dose regimen (RP2D-IE) was identified and
      expansion cohorts in metastatic uveal melanoma was accrued based on prior therapy.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1

Secondary Outcome

 Objective Response Rate in Phase 1

Condition

Uveal Melanoma

Intervention

IMCgp100

Study Arms / Comparison Groups

 Dose escalation
Description:  Dose escalation cohorts of the intra-patient escalation regimen.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

146

Start Date

February 2016

Completion Date

September 20, 2021

Primary Completion Date

June 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female participants age ≥ 18 years of age at the time of informed consent.

          2. Ability to provide and understand written informed consent prior to any study
             procedures.

          3. Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma
             (mUM).

          4. 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.

          5. Human leukocyte antigen (HLA)-A*0201 positive.

          6. ECOG Performance Status of 0 or 1 at Screening.

          7. Phase 2 will include participants with previously treated uveal melanoma in the
             metastatic setting.

        Exclusion Criteria:

          1. Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS
             metastases that require doses of corticosteroids.

          2. History of severe hypersensitivity reactions to other biologic drugs or monoclonal
             antibodies.

          3. Participants with any out-of-range laboratory values.

          4. Clinically significant cardiac disease or impaired cardiac function.

          5. Active infection requiring systemic antibiotic therapy.

          6. Known history of HIV infection.

          7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional
             protocol.

          8. 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.

          9. Malignant disease, other than that being treated in this study.

         10. 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.

         11. 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.

         12. Pregnant, likely to become pregnant, or lactating women.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02570308

Organization ID

IMCgp100-102


Responsible Party

Sponsor

Study Sponsor

Immunocore Ltd


Study Sponsor

, , 


Verification Date

August 2021