IMCgp100-401 Rollover Study

• ClinicalTrials.gov Identifier: NCT02889861
• Recruitment Status: Terminated
• First Posted: September 7, 2016
• Results First Posted: July 27, 2020
• Last Update Posted: July 27, 2020
• Sponsor: Immunocore Ltd
• Information provided by (Responsible Party): Immunocore Ltd

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Malignant Melanoma	Drug: IMCgp100	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multi-center, Rollover Study in Patients With Advanced Melanoma After Completing an IMCgp100 Clinical Study
• Actual Study Start Date: January 11, 2017
• Actual Primary Completion Date: April 22, 2019
• Actual Study Completion Date: April 22, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Regimen 1; IMCgp100 (77 kDa bi-specific protein) weekly dosing regimen (QW)	Drug: IMCgp100; Bispecific soluble human leukocyte antigen-A2 (HLA-A2) restricted gp100-specific TCR fused to anti-CD3

Outcome Measures

Primary Outcome Measures :

1. Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: Up to 2 years and 4 months ]
   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.

Secondary Outcome Measures :

1. Tolerability: Dose Interruptions by Participant - Number of Cycles [ Time Frame: Up to 2 years and 4 months ]
   Tolerability of study treatment was assessed by summarizing the number of treatment dose interruptions, characterized in part by number of cycles started and completed in the rollover study (22 days per cycle).
2. Tolerability: Dose Interruptions by Participant - Duration [ Time Frame: Up to 2 years and 4 months ]
   Tolerability of study treatment was assessed by summarizing the number of treatment dose interruptions, characterized in part by duration of interruption and treatment.
3. Tolerability: Dose Reductions by Participant - Actual Total Dose Received [ Time Frame: Up to 2 years and 4 months ]
   Tolerability of study treatment was assessed by summarizing actual total dose received in micrograms in the rollover study.
4. Tolerability: Dose Reductions by Participant - Dose Intensity [ Time Frame: Up to 2 years and 4 months ]
   Tolerability of study treatment was assessed by summarizing dose intensity, described as actual dose received/actual duration (micrograms per week) in the rollover study.
5. Tolerability: Dose Reductions by Participant - Relative Dose Intensity [ Time Frame: Up to 2 years and 4 months ]
   Tolerability of study treatment was assessed by summarizing the relative dose intensity, described as the ratio of dose intensity to planned dose/planned duration in the rollover study.
6. Overall Survival Status of All Participants Treated With IMCgp100: Number of Months [ Time Frame: Up to 2 years and 4 months ]
   This endpoint was used to estimate the overall survival (OS) in participants treated with IMCgp100. OS is defined as the time from the date of first dose of study drug in the parent study until death due to any cause. Any participant not known to have died at the time of analysis was right-censored based on the last recorded date on which the participant was known to be alive, i.e. the latest of (i) the "Date of death or Last contact" (for those participants still alive) on the End of Study electronic case report form page and (ii) "Date patient last known to be alive" on the Survival Follow Up eCRF page. Number of days was then converted to months.
7. Assessments of Anti-IMCgp100 Antibody Formation: Number of Participants With Anti-IMCgp100 Antibody Formation [ Time Frame: Up to 2 years and 4 months ]
   The concentration/AE - immunogenicity relationship was explored graphically, and tabulated to characterize a relationship between the changes from screening immunogenicity presence and serum concentration of IMCgp100.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

Memorial Slone Kettering Cancer Center

New York, New York, United States, 10065

United Kingdom

Dept of Oncology & Haematology, Churchill Hospital

Oxford, Oxfordshire, United Kingdom, OX3 7LJ

Dept of Medical Oncology, Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom, G12 OYN

Sponsors and Collaborators

Immunocore Ltd

  Study Documents (Full-Text)

Documents provided by Immunocore Ltd:

Statistical Analysis Plan  [PDF] May 9, 2019

Study Protocol  [PDF] November 7, 2016

More Information

• Responsible Party: Immunocore Ltd
• ClinicalTrials.gov Identifier: NCT02889861
• Other Study ID Numbers: IMCgp100-401
• First Posted: September 7, 2016
• Results First Posted: July 27, 2020
• Last Update Posted: July 27, 2020
• Last Verified: July 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Immunocore Ltd:

Uveal melanoma; Cutaneous melanoma

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas