Last updated: 04/16/2026 19:30:08

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination with Feladilimab (GSK3359609) in Participants with RRMM

GSK study ID
208887 Sub Study 2
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Active, not recruiting
Active, not recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)–DREAMM5 - Sub-study 2 – Belantamab Mafodotin and Feladilimab (GSK3359609) in Combination
Trial description: The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with feladilimab (GSK3359609), and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Dose Exploration (DE) Phase: Number of participants with dose limiting toxicities (DLTs)

Timeframe: Up to 21 days

DE Phase: Number of participants with adverse events (AEs)

Timeframe: Up to approximately 281 weeks

DE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry, and urinalysis lab parameters

Timeframe: Up to approximately 281 weeks

Cohort Expansion (CE) Phase: Overall Response Rate (ORR)

Timeframe: Up to approximately 281 weeks

Secondary outcomes:

DE Phase: Overall Response Rate

Timeframe: Up to approximately 380 weeks

CE Phase: Clinical Benefit Rate (CBR)

Timeframe: Up to approximately 380 weeks

DE Phase: Number of participants achieving Partial Response (PR)

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants achieving PR

Timeframe: Up to approximately 380 weeks

DE Phase: Number of participants achieving Very Good Partial Response (VGPR)

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants achieving VGPR

Timeframe: Up to approximately 380 weeks

DE Phase: Number of participants achieving Complete Response (CR)

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants achieving CR

Timeframe: Up to approximately 380 weeks

DE Phase: Number of participants achieving Stringent Complete Response (sCR)

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants achieving sCR

Timeframe: Up to approximately 380 weeks

DE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments

Timeframe: Up to approximately 380 weeks

CE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments

Timeframe: Up to approximately 380 weeks

DE Phase: Feladilimab concentration when administered in combination with belantamab mafodotin

Timeframe: Up to approximately 380 weeks

CE Phase: Feladilimab concentration when administered in combination with belantamab mafodotin

Timeframe: Up to approximately 380 weeks

DE Phase: Number of participants with anti-drug antibodies (ADAs) against belantamab mafodotin

Timeframe: Up to approximately 380 weeks

DE Phase: Titre of (ADAs) against belantamab mafodotin

Timeframe: Up to approximately 380 weeks

DE Phase: Number of participants with anti-drug antibodies (ADAs) against feladilimab

Timeframe: Up to approximately 380 weeks

DE Phase: Titre of (ADAs) against feladilimab

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants with ADAs against belantamab mafodotin

Timeframe: Up to approximately 380 weeks

CE Phase: Titre of ADAs against belantamab mafodotin

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants with ADAs against feladilimab

Timeframe: Up to approximately 380 weeks

CE Phase: Titre of ADAs against feladilimab

Timeframe: Up to approximately 380 weeks

DE Phase: Number of participants with adverse events of special interest (AESI) for belantamab mafodotin

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants with AESI for belantamab mafodotin

Timeframe: Up to approximately 380 weeks

DE Phase: Number of participants with AESI for feladilimab

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants with AESI for feladilimab

Timeframe: Up to approximately 380 weeks

DE Phase: Number of participants with abnormal ocular findings on ophthalmic examination

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants with abnormal ocular findings on ophthalmic examination

Timeframe: Up to approximately 380 weeks

CE Phase: Progression-free survival (PFS)

Timeframe: Up to approximately 380 weeks

CE Phase: Duration of response (DoR)

Timeframe: Up to approximately 380 weeks

CE Phase: Time to response (TTR)

Timeframe: Up to approximately 380 weeks

CE Phase: Overall survival (OS)

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants with AEs and SAEs

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants with AEs leading to discontinuation

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants with AE leading to dose reduction or delay

Timeframe: Up to approximately 380 weeks

CE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters

Timeframe: Up to approximately 380 weeks

Interventions:
Drug: Belantamab mafodotin
Drug: Feladilimab
Enrollment:
25
Observational study model:
Not applicable
Primary completion date:
2025-17-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2019 to March 2027
Type
Interventional
Phase
1/2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participant must be 18 years of age inclusive or older, at the time of signing the informed consent.
  • Participants must have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG.
  • Participants with current corneal epithelial disease except mild punctate keratopathy.
  • Participants with evidence of cardiovascular risk.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Fitzroy, VIC, Australia, 3065
Status
Study Complete
Location
GSK Investigational Site
Melbourne, VIC, Australia, 3000
Status
Study Complete
Location
GSK Investigational Site
Vancouver, BC, Canada, V5Z1M9
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M5G2M9
Status
Recruitment Complete
Location
GSK Investigational Site
VILLEJUIF CEDEX, France, 94805
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22083
Status
Study Complete
Location
GSK Investigational Site
UTRECHT, Netherlands, 3584CX
Status
Study Complete
Location
GSK Investigational Site
Pamplona Navarra, Spain, 31008
Status
Study Complete
Location
GSK Investigational Site
Stockholm, Sweden, SE-141 86
Status
Study Complete
Location
GSK Investigational Site
Atlanta, GA, United States, 30322
Status
Study Complete
Location
GSK Investigational Site
Madison, WI, United States, 53792
Status
Recruitment Complete

Study documents

Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Active, not recruiting
Actual primary completion date
2025-17-04
Actual study completion date
Not applicable

Plain language summaries

Summary of results in plain language
Available language(s): English, Dutch, French (Canadian), French, German, Spanish, Spanish (United States), Swedish

To view plain language summaries on trialsummaries.com click here.

Additional information about the trial

Additional information
Not applicable
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