Clinical trial · Interventional
IMCgp100-401 Rollover Study
An Open-label, Multi-center, Rollover Study in Patients With Advanced Melanoma After Completing an IMCgp100 Clinical Study
NCT02889861CI-TRIAL-00046200terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMCgp100 | Drug | Tebentafusp | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Regimen 1
- description
- IMCgp100 (77 kDa bi-specific protein) weekly dosing regimen (QW)
- interventionNames
- Drug: IMCgp100
Primary outcomes (1)
- measure
- Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events
- timeFrame
- Up to 2 years and 4 months
- description
- 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 outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.