Trial Outcomes & Findings for IMCgp100-401 Rollover Study (NCT NCT02889861)

NCT ID: NCT02889861

Last Updated: 2020-07-27

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: Up to 2 years and 4 months
• Results posted on: 2020-07-27

Participant Flow

Eligible participants have tolerated IMCgp100 (77 kDa bi-specific protein) 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.

Participants were eligible for enrollment in this study from parent studies that have completed and satisfied its primary endpoints or have been terminated by the Sponsor for reasons other than safety.

Participant milestones

Measure	Regimen 1 IMCgp100 weekly dosing regimen (QW)
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Regimen 1 IMCgp100 weekly dosing regimen (QW)
Overall Study Ongoing in Survival Follow-up	2

Baseline Characteristics

IMCgp100-401 Rollover Study

Baseline characteristics by cohort

Measure	Regimen 1 n=3 Participants IMCgp100 weekly dosing regimen (QW) IMCgp100: Bispecific soluble HLA-A2 restricted gp100-specific TCR fused to anti-CD3
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years and 4 months

Population: Safety Analysis Set (SAF) includes all participants who have received at least 1 full or partial dose of IMCgp100.

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.

Outcome measures

Measure	Regimen 1 n=3 Participants IMCgp100 weekly dosing regimen (QW)	Participant 4002001 Regimen 1 MCgp100 weekly dosing regimen (QW)	Participant 4003001 Regimen 1 MCgp100 weekly dosing regimen (QW)
Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events Any TEAE	2 participants	—	—
Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events Any TEAE related to IMCgp100 by Investigator	2 participants	—	—
Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events Any TEAE leading to death	0 participants	—	—
Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events Any TEAE leading to discontinuation of study drug	0 participants	—	—
Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events Any TEAE of CTCAE Grade ≥3	2 participants	—	—
Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events Any TEAE of CTCAE Grade ≥3 and related to IMCgp100	1 participants	—	—
Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events Any serious TEAE	0 participants	—	—
Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events Any serious TEAE related to IMCgp100	0 participants	—	—

SECONDARY outcome

Timeframe: Up to 2 years and 4 months

Population: SAF

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).

Outcome measures

Measure	Regimen 1 n=1 Participants IMCgp100 weekly dosing regimen (QW)	Participant 4002001 Regimen 1 n=1 Participants MCgp100 weekly dosing regimen (QW)	Participant 4003001 Regimen 1 n=1 Participants MCgp100 weekly dosing regimen (QW)
Tolerability: Dose Interruptions by Participant - Number of Cycles Number of cycles started (rollover)	2 Number of cycles	26 Number of cycles	18 Number of cycles
Tolerability: Dose Interruptions by Participant - Number of Cycles Number of cycles completed (rollover)	1 Number of cycles	25 Number of cycles	17 Number of cycles

SECONDARY outcome

Timeframe: Up to 2 years and 4 months

Population: SAF

Tolerability of study treatment was assessed by summarizing the number of treatment dose interruptions, characterized in part by duration of interruption and treatment.

Outcome measures

Measure	Regimen 1 n=1 Participants IMCgp100 weekly dosing regimen (QW)	Participant 4002001 Regimen 1 n=1 Participants MCgp100 weekly dosing regimen (QW)	Participant 4003001 Regimen 1 n=1 Participants MCgp100 weekly dosing regimen (QW)
Tolerability: Dose Interruptions by Participant - Duration Duration of IMCgp100 treatment on rollover study	43 Days	728 Days	505 Days
Tolerability: Dose Interruptions by Participant - Duration Duration of IMCgp100 treatment from parent study	423 Days	1156 Days	960 Days
Tolerability: Dose Interruptions by Participant - Duration Duration of interruption on rollover study	0 Days	0 Days	0 Days

SECONDARY outcome

Timeframe: Up to 2 years and 4 months

Population: SAF

Tolerability of study treatment was assessed by summarizing actual total dose received in micrograms in the rollover study.

Outcome measures

Measure	Regimen 1 n=1 Participants IMCgp100 weekly dosing regimen (QW)	Participant 4002001 Regimen 1 n=1 Participants MCgp100 weekly dosing regimen (QW)	Participant 4003001 Regimen 1 n=1 Participants MCgp100 weekly dosing regimen (QW)
Tolerability: Dose Reductions by Participant - Actual Total Dose Received	350 Micrograms	5100 Micrograms	3500 Micrograms

SECONDARY outcome

Timeframe: Up to 2 years and 4 months

Population: SAF

Tolerability of study treatment was assessed by summarizing dose intensity, described as actual dose received/actual duration (micrograms per week) in the rollover study.

Outcome measures

Measure	Regimen 1 n=1 Participants IMCgp100 weekly dosing regimen (QW)	Participant 4002001 Regimen 1 n=1 Participants MCgp100 weekly dosing regimen (QW)	Participant 4003001 Regimen 1 n=1 Participants MCgp100 weekly dosing regimen (QW)
Tolerability: Dose Reductions by Participant - Dose Intensity	57.0 Micrograms per week	49.0 Micrograms per week	48.5 Micrograms per week

SECONDARY outcome

Timeframe: Up to 2 years and 4 months

Population: SAF

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.

Outcome measures

Measure	Regimen 1 n=1 Participants IMCgp100 weekly dosing regimen (QW)	Participant 4002001 Regimen 1 n=1 Participants MCgp100 weekly dosing regimen (QW)	Participant 4003001 Regimen 1 n=1 Participants MCgp100 weekly dosing regimen (QW)
Tolerability: Dose Reductions by Participant - Relative Dose Intensity	100.0 Percent	100.0 Percent	100.0 Percent

SECONDARY outcome

Timeframe: Up to 2 years and 4 months

Population: Full Analysis Set (FAS) comprises all participants assigned to treatment, who received at least 1 full or partial dose of IMCgp100.

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.

Outcome measures

Measure	Regimen 1 n=3 Participants IMCgp100 weekly dosing regimen (QW)	Participant 4002001 Regimen 1 MCgp100 weekly dosing regimen (QW)	Participant 4003001 Regimen 1 MCgp100 weekly dosing regimen (QW)
Overall Survival Status of All Participants Treated With IMCgp100: Number of Months Baseline to Death	27.0 months	—	—
Overall Survival Status of All Participants Treated With IMCgp100: Number of Months Baseline to Study Terminated by Sponsor	41.0 months	—	—
Overall Survival Status of All Participants Treated With IMCgp100: Number of Months Baseline to Alive	41.0 months	—	—

SECONDARY outcome

Timeframe: Up to 2 years and 4 months

Population: SAF

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.

Outcome measures

Measure	Regimen 1 n=3 Participants IMCgp100 weekly dosing regimen (QW)	Participant 4002001 Regimen 1 MCgp100 weekly dosing regimen (QW)	Participant 4003001 Regimen 1 MCgp100 weekly dosing regimen (QW)
Assessments of Anti-IMCgp100 Antibody Formation: Number of Participants With Anti-IMCgp100 Antibody Formation	2 participants	—	—

Adverse Events

Regimen 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Regimen 1 n=3 participants at risk IMCgp100 weekly dosing regimen (QW)
Eye disorders Blepharitis	33.3% 1/3 • Number of events 1 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Gastrointestinal disorders Gastrooesophageal reflux disease	33.3% 1/3 • Number of events 1 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 2 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
General disorders Chills	33.3% 1/3 • Number of events 1 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • Number of events 1 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Investigations ALT increased	33.3% 1/3 • Number of events 1 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Investigations AST increased	33.3% 1/3 • Number of events 2 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Investigations Lipase increased	33.3% 1/3 • Number of events 5 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Investigations White blood cell count decreased	33.3% 1/3 • Number of events 2 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 1/3 • Number of events 2 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • Number of events 4 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 2 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 6 • Up to 2 years and 4 months All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.

Additional Information

Chris Holland, Executive Director Head of Biometrics

Immunocore, LLC

Phone: 1-267-589-9204

Email: chris.holland2@immunocore.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication/presentation (manuscript, abstract or poster) to a journal/scientific meeting is sent to sponsor for review at least 1 month before submission who may delay submission by up to 90 days if it reasonably believes that publication of results may compromise its intellectual property rights or else insist that such data are removed. No single center/groups of centers may publish individually. Publication will not include confidential information without the permission of the sponsor.
• Publication restrictions are in place

Restriction type: OTHER