IMCgp100-401 Rollover Study

NCT ID: NCT02889861

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-11
• Study Completion Date: 2019-04-22

Brief Summary

IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for eligible participants with advanced melanoma who have previously participated in an IMCgp100 study (parent study).

Detailed Description

IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for eligible participants with advanced melanoma who have previously participated in an IMCgp100 study (parent study). Parent studies that are eligible for participants to continue to receive IMCgp100 in this rollover study must have completed and satisfied its primary endpoints or have been terminated by the Sponsor for reasons other than safety.

Eligible participants will have tolerated IMCgp100 for a minimum of 4 weeks of dosing without significant toxicities that would preclude further dosing in the opinion of the principal investigator or Sponsor.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regimen 1

IMCgp100 (77 kDa bi-specific protein) weekly dosing regimen (QW)

Group Type: EXPERIMENTAL

IMCgp100

Intervention Type: DRUG

Bispecific soluble human leukocyte antigen-A2 (HLA-A2) restricted gp100-specific TCR fused to anti-CD3

Interventions

IMCgp100

Bispecific soluble human leukocyte antigen-A2 (HLA-A2) restricted gp100-specific TCR fused to anti-CD3

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participant is currently participating in an Immunocore-sponsored study of IMCgp100 and is actively receiving IMCgp100. Participant must have fulfilled all required assessments in the parent study (unless the study is being terminated)

2. Participant is currently receiving clinical benefit from the treatment with IMCgp100, as determined by the principal investigator from the parent study

3. Participant has demonstrated compliance with the parent study requirements, as assessed by the principal investigator and participant is able to comply with the necessary visits and assessments as part of the rollover study

4. Written informed consent must be obtained prior to enrolling in the rollover study and receiving the study treatment. If consent cannot be expressed in writing, then the consent must be formally documented and witnessed, ideally via an independent trusted witness

Exclusion Criteria

1. Participant has been permanently discontinued from any IMCgp100 study or from IMCgp100 treatment in the parent study due to unequivocal progressive disease, unacceptable toxicity, non-compliance to study procedures, withdrawal of consent, or any other reason

2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test

3. Women of child-bearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using 2 methods of highly effective contraception from Screening, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods include barrier methods, intrauterine devices or hormonal methods. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Women of child-bearing potential must have a negative serum pregnancy test at Screening. Otherwise, female participants must be post-menopausal (no menstrual period for at least 12 months prior to Screening), or surgically sterile

4. Male participants who are not surgically sterile unless they are using a double barrier contraception method from enrollment through treatment and for 6 months following administration of the last dose of study drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunocore Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; United Kingdom

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

IMCgp100-401

Identifier Type: -

Identifier Source: org_study_id