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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06160609




Registration number
NCT06160609
Ethics application status
Date submitted
29/11/2023
Date registered
7/12/2023

Titles & IDs
Public title
Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM
Scientific 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 1 - Belantamab Mafodotin and aOX40 (GSK3174998) in Combination
Secondary ID [1] 0 0
2019-001138-32
Secondary ID [2] 0 0
208887 Sub Study 1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Belantamab Mafodotin
Treatment: Drugs - GSK3174998

Experimental: Belantamab mafodotin + GSK3174998 -


Treatment: Drugs: Belantamab Mafodotin
Belantamab Mafodotin will be administered.

Treatment: Drugs: GSK3174998
GSK3174998 will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
DE Phase: Number of Participants With Dose Limiting Toxicities (DLT)
Timepoint [1] 0 0
Up to 21 days
Primary outcome [2] 0 0
DE Phase: Number of Participants With Adverse Events (AEs)
Timepoint [2] 0 0
Up to 170 weeks
Primary outcome [3] 0 0
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Timepoint [3] 0 0
Baseline (Day 1) and up to 170 weeks
Primary outcome [4] 0 0
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Timepoint [4] 0 0
Baseline (Day 1) and up to 170 weeks
Primary outcome [5] 0 0
Cohort Expansion (CE) Phase: Overall Response Rate (ORR)
Timepoint [5] 0 0
Up to 170 weeks
Secondary outcome [1] 0 0
DE Phase: Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to 170 weeks
Secondary outcome [2] 0 0
CE Phase: Clinical Benefit Rate (CBR)
Timepoint [2] 0 0
Up to 170 weeks
Secondary outcome [3] 0 0
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
Timepoint [3] 0 0
Up to 170 weeks
Secondary outcome [4] 0 0
CE Phase: Percentage of Participants Achieving SCR, CR, VGPR and PR
Timepoint [4] 0 0
Up to 170 weeks
Secondary outcome [5] 0 0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
Timepoint [5] 0 0
Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)
Secondary outcome [6] 0 0
CE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
Timepoint [6] 0 0
Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)
Secondary outcome [7] 0 0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody
Timepoint [7] 0 0
Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)
Secondary outcome [8] 0 0
CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody
Timepoint [8] 0 0
Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)
Secondary outcome [9] 0 0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Timepoint [9] 0 0
Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)
Secondary outcome [10] 0 0
CE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Timepoint [10] 0 0
Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)
Secondary outcome [11] 0 0
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin
Timepoint [11] 0 0
Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)
Secondary outcome [12] 0 0
CE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin
Timepoint [12] 0 0
Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)
Secondary outcome [13] 0 0
DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Timepoint [13] 0 0
Up to 170 weeks
Secondary outcome [14] 0 0
CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin
Timepoint [14] 0 0
Up to 170 weeks
Secondary outcome [15] 0 0
DE Phase: Number of Participants With Post-baseline Positive ADAs Against OX40
Timepoint [15] 0 0
Up to 170 weeks
Secondary outcome [16] 0 0
CE Phase: Number of Participants With Post-baseline Positive ADAs Against OX40
Timepoint [16] 0 0
Up to 170 weeks
Secondary outcome [17] 0 0
DE Phase: Concentration of ADAs Against Belantamab Mafodotin
Timepoint [17] 0 0
Up to 170 weeks
Secondary outcome [18] 0 0
CE Phase: Concentration of ADAs Against Belantamab Mafodotin
Timepoint [18] 0 0
Up to 170 weeks
Secondary outcome [19] 0 0
DE Phase: Concentration of ADAs Against OX40 When Administered in Combination With Belantamab Mafodotin
Timepoint [19] 0 0
Up to 170 weeks
Secondary outcome [20] 0 0
CE Phase: Concentration of ADAs Against OX40 When Administered in Combination With Belantamab Mafodotin
Timepoint [20] 0 0
Up to 170 weeks
Secondary outcome [21] 0 0
DE Phase: Number of Participants With Adverse Events of Special Interest (AESI)
Timepoint [21] 0 0
Up to 170 weeks
Secondary outcome [22] 0 0
CE Phase: Number of Participants With AESI
Timepoint [22] 0 0
Up to 170 weeks
Secondary outcome [23] 0 0
DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade
Timepoint [23] 0 0
Up to 170 weeks
Secondary outcome [24] 0 0
CE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade
Timepoint [24] 0 0
Up to 170 weeks
Secondary outcome [25] 0 0
CE Phase: Progression-free Survival (PFS)
Timepoint [25] 0 0
Up to 170 weeks
Secondary outcome [26] 0 0
CE Phase: Duration of Response (DoR)
Timepoint [26] 0 0
Up to 170 weeks
Secondary outcome [27] 0 0
CE Phase: Time to Response (TTR)
Timepoint [27] 0 0
Up to 170 weeks
Secondary outcome [28] 0 0
CE Phase: Overall Survival (OS)
Timepoint [28] 0 0
Up to 170 weeks
Secondary outcome [29] 0 0
CE Phase: Number of Participants With AEs and SAEs
Timepoint [29] 0 0
Up to 170 weeks
Secondary outcome [30] 0 0
CE Phase: Number of Participants With AEs Leading to Discontinuation
Timepoint [30] 0 0
Up to 170 weeks
Secondary outcome [31] 0 0
CE Phase: Number of Participants With Dose Reduction or Delay
Timepoint [31] 0 0
Up to 170 weeks
Secondary outcome [32] 0 0
CE Phase: Number of Participants With Clinically Significant Changes in Hematology Lab Parameters
Timepoint [32] 0 0
Up to 170 weeks
Secondary outcome [33] 0 0
CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters
Timepoint [33] 0 0
Up to 170 weeks

Eligibility
Key inclusion criteria
* 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 having at least 3 prior lines of prior anti-myeloma treatments including an immunomodulating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
* Participants with a history of autologous stem cell transplant are eligible for study participation when, transplant was >100 days prior to study enrolment and with no active infection(s).
* Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, unless ECOG less than equal to (<=)2 is due solely to skeletal complications and/or skeletal pain due to MM.
* Participants with measurable disease defined as at least one of the following: Serum M-protein greater than equal to (>=)0.5 gram per deciliter (>=5 gram per liter) or Urine M-protein >=200 milligrams (mg) per 24 hours or Serum free light chain (FLC) assay: Involved FLC level >=10 mg per deciliter (>=100 mg per Liter) and an abnormal serum FLC ratio (<0.26 or >1.65).
* Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV deoxyribonucleic acid (DNA) undetectable during screening.
* Participants who are currently receiving physiological doses oral steroids (<10 mg/day), inhaled steroids or ophthalmological steroids.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with current corneal epithelial disease except mild punctate keratopathy.
* Participants with evidence of cardiovascular risk.
* Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb.
* Participants with active infection requiring antibiotic, antiviral, or antifungal treatment.
* Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within <14 days.
* Participants with prior radiotherapy within 2 weeks of start of study therapy.
* Participants with prior allogeneic transplant are prohibited.
* Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
* Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days.
* Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter.
* Participants with >=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation.
* Participants who have received transfusion of blood products within 2 weeks before the first dose of study drug.
* Participants must not receive live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in any sub-study arm of the platform trial and for at least 70 days following last study treatment.
* Participants with presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM.
* Participants with known human immunodeficiency virus (HIV) infection, unless the participant can meet all criteria: a) established anti-retroviral therapy for at least 4 weeks and HIV viral load<400 copies/milliliter (mL) b) cluster of differentiation 4 plus (CD4+) T-cell (CD4+) counts >= 350 cells/microliter (µL) c) No history of Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months in which case the participant would be eligible for CE Phase only.
* Participants with autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years.
* Exclusion for a recent (within the past 6 months) history of symptomatic pericarditis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/01/2023
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Sweden
State/province [2] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT06160609