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IMCgp100-401 Rollover Study

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ClinicalTrials.gov Identifier: NCT02889861
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Immunocore Ltd

Brief Summary:
IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for eligible patients 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 patients with advanced melanoma who have previously participated in an IMCgp100 study (parent study). Parent studies that are eligible for patients 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 patients 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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 18, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Experimental: Regimen 1
IMCgp100 weekly dosing regimen (QW)
Drug: IMCgp100
Bispecific soluble HLA-A2 restricted gp100-specific TCR fused to anti-CD3




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Tolerability: Dose interruptions, reductions, and dose intensity of IMCgp100 [ Time Frame: 4 years ]
  2. Assessments of anti-IMCgp100 antibody formation [ Time Frame: 4 years ]
  3. Date of death in all patients treated with IMCgp100 [ Time Frame: 4 years ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patient is currently participating in an Immunocore-sponsored study of IMCgp100 and is actively receiving IMCgp100. Patient must have fulfilled all required assessments in the parent study (unless the study is being terminated)
  2. Patient is currently receiving clinical benefit from the treatment with IMCgp100, as determined by the principal investigator from the parent study
  3. Patient has demonstrated compliance with the parent study requirements, as assessed by the principal investigator and patient 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. Patient 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 patients must be post-menopausal (no menstrual period for at least 12 months prior to Screening), or surgically sterile
  4. Male patients 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

Information from the National Library of Medicine

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): NCT02889861


Contacts
Contact: Rachael Easton, MD, PhD 484-534-5261 rachael.easton@immunocore.com
Contact: Julia Hamlin 01235 776824 (Ext 6284) Julia.Hamlin@immunocore.com

Locations
United States, New York
Memorial Slone Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Alexander Shoustari, MD         
Principal Investigator: Alexander Shoustari, MD         
United Kingdom
Dept of Oncology & Haematology, Churchill Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Contact: Mark Middleton, MD         
Principal Investigator: Mark Middleton, MD         
Dept of Medical Oncology, Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom, G12 OYN
Contact: Jeff Evans, MD, FRCP         
Principal Investigator: Jeff Evans, MD, FRCP         
Sponsors and Collaborators
Immunocore Ltd

Responsible Party: Immunocore Ltd
ClinicalTrials.gov Identifier: NCT02889861     History of Changes
Other Study ID Numbers: IMCgp100-401
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

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