Overview
Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM
Status:
Terminated
Terminated
Trial end date:
2023-01-09
2023-01-09
Target enrollment:
0
0
Participant gender:
All
All
Summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each combination treatment to explore in the cohort expansion phase. This study is the sub study of the Master protocol (NCT04126200).Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
GlaxoSmithKline
Criteria
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.
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.