NCT02889861

IMCgp100-401 Rollover Study

Terminated Phase 2 Results posted Last updated 27 July 2020

What this trial tests

Phase 2 trial testing IMCgp100 in Malignant Melanoma in 3 participants. Terminated before completion.

Timeline

11 January 2017

Primary endpoint
22 April 2019

22 April 2019

Quick facts

Lead sponsor	Immunocore Ltd
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	11 January 2017
Primary completion	22 April 2019
Estimated completion	22 April 2019
Sites	3 locations across United Kingdom, United States

Drugs / interventions tested

• IMCgp100

Conditions studied

• Malignant Melanoma — all drugs for Malignant Melanoma →

Sponsor

Immunocore Ltd — full company profile →

Who can join

18 and older, any sex, with Malignant Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events Primary · 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

Any TEAE

Group	Value	95% CI
Regimen 1	2

Any TEAE of CTCAE Grade ≥3

Group	Value	95% CI
Regimen 1	2

Any TEAE related to IMCgp100 by Investigator

Group	Value	95% CI
Regimen 1	2

Any TEAE of CTCAE Grade ≥3 and related to IMCgp100

Group	Value	95% CI
Regimen 1	1

Any serious TEAE

Group	Value	95% CI
Regimen 1	0

Any serious TEAE related to IMCgp100

Group	Value	95% CI
Regimen 1	0

Any TEAE leading to death

Group	Value	95% CI
Regimen 1	0

Any TEAE leading to discontinuation of study drug

Group	Value	95% CI
Regimen 1	0

Tolerability: Dose Interruptions by Participant - Number of Cycles Secondary · 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).

Number of cycles started (rollover)

Group	Value	95% CI
Participant 4001001 Regimen 1	2
Participant 4002001 Regimen 1	26
Participant 4003001 Regimen 1	18

Number of cycles completed (rollover)

Group	Value	95% CI
Participant 4001001 Regimen 1	1
Participant 4002001 Regimen 1	25
Participant 4003001 Regimen 1	17

Tolerability: Dose Interruptions by Participant - Duration Secondary · 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.

Duration of IMCgp100 treatment on rollover study

Group	Value	95% CI
Participant 4001001 Regimen 1	43
Participant 4002001 Regimen 1	728
Participant 4003001 Regimen 1	505

Duration of interruption on rollover study

Group	Value	95% CI
Participant 4001001 Regimen 1	0
Participant 4002001 Regimen 1	0
Participant 4003001 Regimen 1	0

Duration of IMCgp100 treatment from parent study

Group	Value	95% CI
Participant 4001001 Regimen 1	423
Participant 4002001 Regimen 1	1156
Participant 4003001 Regimen 1	960

Tolerability: Dose Reductions by Participant - Actual Total Dose Received Secondary · 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.

Group	Value	95% CI
Participant 4001001 Regimen 1	350
Participant 4002001 Regimen 1	5100
Participant 4003001 Regimen 1	3500

Tolerability: Dose Reductions by Participant - Dose Intensity Secondary · 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.

Group	Value	95% CI
Participant 4001001 Regimen 1	57.0
Participant 4002001 Regimen 1	49.0
Participant 4003001 Regimen 1	48.5

Tolerability: Dose Reductions by Participant - Relative Dose Intensity Secondary · 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.

Group	Value	95% CI
Participant 4001001 Regimen 1	100.0
Participant 4002001 Regimen 1	100.0
Participant 4003001 Regimen 1	100.0

Overall Survival Status of All Participants Treated With IMCgp100: Number of Months Secondary · 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 U

Baseline to Death

Group	Value	95% CI
Regimen 1	27.0

Baseline to Study Terminated by Sponsor

Group	Value	95% CI
Regimen 1	41.0

Baseline to Alive

Group	Value	95% CI
Regimen 1	41.0

Assessments of Anti-IMCgp100 Antibody Formation: Number of Participants With Anti-IMCgp100 Antibody Formation Secondary · 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.

Group	Value	95% CI
Regimen 1	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 years and 4 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Regimen 1

Serious: 0/3 (0%)

Deaths: 1/3

Other adverse events (14 terms — click to expand)

Reaction	System	Regimen 1
Blepharitis	Eye disorders	—
Constipation	Gastrointestinal disorders	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Chills	General disorders	—
Upper respiratory tract infection	Infections and infestations	—
ALT increased	Investigations	—
AST increased	Investigations	—
Lipase increased	Investigations	—
White blood cell count decreased	Investigations	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—
Hypomagnesaemia	Metabolism and nutrition disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Hypertension	Vascular disorders	—

Data from ClinicalTrials.gov NCT02889861 adverse events section.

Sponsor's own 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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Melanoma treatment in review.
   Domingues B, Lopes JM, Soares P, Pópulo H. · · 2018 · cited 432× · PMID 29922629 · DOI 10.2147/itt.s134842
2. Engineered T Cell Therapy for Cancer in the Clinic.
   Zhao L, Cao YJ. · · 2019 · cited 275× · PMID 31681259 · DOI 10.3389/fimmu.2019.02250
3. Biology drives the discovery of bispecific antibodies as innovative therapeutics.
   Nie S, Wang Z, Moscoso-Castro M, D'Souza P, et al · · 2020 · cited 79× · PMID 33928225 · DOI 10.1093/abt/tbaa003
4. Melanoma therapeutics: a literature review.
   Dhanyamraju PK, Patel TN. · · 2022 · cited 36× · PMID 35260531 · DOI 10.7555/jbr.36.20210163
5. Discovery Strategies to Maximize the Clinical Potential of T-Cell Engaging Antibodies for the Treatment of Solid Tumors.
   Voynov V, Adam PJ, Nixon AE, Scheer JM. · · 2020 · cited 17× · PMID 33217946 · DOI 10.3390/antib9040065
6. The role of signaling pathways mediated by the GPCRs CysLTR1/2 in melanocyte proliferation and senescence.
   Huber T, Horioka-Duplix M, Chen Y, Saca VR, et al · · 2024 · cited 5× · PMID 39288219 · DOI 10.1126/scisignal.adp3967
7. Advances and Challenges in Immunotherapy for Metastatic Uveal Melanoma: Clinical Strategies and Emerging Targets.
   Grigoruta M, Kong X, Qin Y. · · 2025 · cited 1× · PMID 40725830 · DOI 10.3390/jcm14145137