IMCgp100-401 Rollover Study

NCT02889861 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: IMCgp100-401
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 3

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).

Conditions

Malignant Melanoma

Keywords

Uveal melanoma; Cutaneous melanoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events

  Incidence of adverse events was presented as the number of participants with treatment-emergent adverse events (TEAEs). TEAEs were defined as adverse events (AEs) that started or worsened in severity from the date of first dose of the rollover study (regardless of time) up until 90 days after the last dose of study drug of this rollover study. Participants with multiple events in the same category were counted only once in that category. Participants with events in more than 1 category were counted once in each of those categories. TEAEs indicated considered related to IMCgp100 were determined by the investigator to be possibly related or related to study drug.

  Up to 2 years and 4 months

Secondary Outcomes (7)

• Tolerability: Dose Interruptions by Participant - Number of Cycles

  Up to 2 years and 4 months

• Tolerability: Dose Interruptions by Participant - Duration

  Up to 2 years and 4 months

• Tolerability: Dose Reductions by Participant - Actual Total Dose Received

  Up to 2 years and 4 months

• Tolerability: Dose Reductions by Participant - Dose Intensity

  Up to 2 years and 4 months

• Tolerability: Dose Reductions by Participant - Relative Dose Intensity

  Up to 2 years and 4 months

Study Arms (1)

Regimen 1

EXPERIMENTAL

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

Drug: IMCgp100

Interventions

IMCgp100 DRUG

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

Regimen 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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
• 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

Sponsors & Collaborators

• Immunocore Ltd: lead

Study Sites (3)

Memorial Slone Kettering Cancer Center

New York, New York, 10065, United States

Location

Dept of Oncology & Haematology, Churchill Hospital

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Dept of Medical Oncology, Beatson West of Scotland Cancer Centre

Glasgow, G12 OYN, United Kingdom

Location

MeSH Terms

Conditions

Melanoma; Uveal Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases

Results Point of Contact

• Title: Chris Holland, Executive Director Head of Biometrics
• Organization: Immunocore, LLC

chris.holland2@immunocore.com

1-267-589-9204

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: January 11, 2017
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: July 27, 2020
• Results First Posted: July 27, 2020

Record last verified: 2020-07

Locations

GB (2); US (1)