Relapsed Refractory Multiple Myeloma (RRMM)Phase 1NCT07831122
Study of Belantamab Mafodotin, Cevostamab, Pomalidomide for RRMM Patients (MAPLE)
A Phase 1 study testing Belamaf, Cevostamab and Pomalidomide in people with Relapsed Refractory Multiple Myeloma (RRMM), run by Canadian Myeloma Research Group at 7 sites in Canada.
Trial summary
This study will evaluate efficacy and tolerability various doses of belantamab mafodotin in combination with cevostamab and pomalidomide in patients with multiple myeloma who have relapsed disease after two or more lines of therapy and/or have refractory to treatment disease. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Relapsed Refractory Multiple Myeloma (RRMM)
- What is being tested?
- Belamaf, Cevostamab and Pomalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 7 sitesCanada
- Study dates
- Dec 2026to Mar 2033
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be able to understand and voluntarily sign an informed consent form (ICF).
- Must be ≥ 18 years of age at the time of signing the ICF.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Documented diagnosis of MM and must have:
- (Part 1) relapsed and refractory disease having previously received 2 or more prior lines and having previously received lenalidomide, a proteosome inhibitor and/or anti-CD38 mAb (triple class exposed) and must be refractory to the last line of therapy.
- (Part 2) relapsed disease having previously received 1-3 prior line of therapy including lenalidomide, a proteosome inhibitor, and/or an anti-CD38 mAb .
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- Lines of therapy are defined as per the consensus panel of the International Myeloma Workshop and include induction therapy followed by ASCT and consolidation/maintenance as one line.
- Relapse is defined as documented evidence of progressive disease (PD) after achieving at least stable disease (SD) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM). and refractory is defined as disease progression during or within 60 days from the end of the most recent MM treatment.
- Subjects with measurable disease defined as at least one of the following (these baseline laboratory studies for determining eligibility must be obtained within 28 days prior to start of study drug):
- Serum M-protein ≥ 5 g/l
- Urine M-protein ≥ 200 mg/24 h
- Serum free light chains (FLC) assay: Involved FLC level ≥ 100 mg/l and an abnormal serum free light chain ratio (< 0.26 or > 1.65).
- Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met:
- Transplant was > 100 days prior to study enrollment
- Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Adequate organ system function defined as:
- Absolute neutrophil count (ANC) > 1.0 x 109/L. Granulocyte colony-stimulating factor (G-CSF) cannot be given within 7 days prior to first study drug administration.
- Hemoglobin ≥ 8.0 g/dL.
- Platelet count >75 x 109/L.
- Serum alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 x ULN, unless known to have Gilbert's disease. If Gilberts, isolated bilirubin >1.5 and <3xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%.
- Estimated glomerular filtration rate (eGFR) (MDRD) ≥ 30 mL/min.
- Albumin/creatinine ratios (spot urine) <500mg/g (56 mg/mmol).
- Albumin ≥ 2.0 g/dL (20 g/L).
- Left ventricular ejection fraction (LVEF) >50%.
- Serum calcium (corrected for albumin) level ≤11.5 mg/dL (treatment of hypercalcemia is allowed and patient may enroll if hypercalcemia returns to Grade ≤1 with standard treatment).
- All prior treatment-related toxicities must be Grade <1 at the time of screening except for alopecia (any grade), neuropathy (Grade <2), cataracts or endocrinopathy managed with replacement therapy (any grade).
- For women of childbearing potential and males: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
- Male Participants:
- Male participants are eligible to participate if they agree to the following during the intervention period and for at 6 months after the last dose of study intervention to allow for clearance of any altered sperm:
- Refrain from donating sperm.
- PLUS, either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
- OR c. Must agree to use contraception/barrier as detailed below: d. Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
- Female Participants:
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP). OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the intervention period and for at least 5 months after the last dose of study intervention.
- A WOCBP must have a negative highly sensitive pregnancy test [serum] as required by local regulations) within 72 hours before the first dose of study intervention and agree to use effective contraception during the study and for 5 months after the last dose of cevostamab, 3 months after the last dose of tocilizumab and 4 months after the last dose of belamaf.
Who cannot join
- Prior treatment with bispecific or BCMA targeted antibody drug conjugate. Note prior anti-BCMA CAR T-cell therapy is permitted provided that the subject achieved a response of partial response (PR) or better and did not progress within 12 months of CAR T-cell infusion.
- Prior exposure to FcRH5 targeted therapy.
- Life-expectancy less than or equal to 12 weeks.
- WOCBP who are pregnant or lactating.
- Known history of amyloidosis, POEMS syndrome, active plasma cell leukemia (defined as circulating plasma cell count exceeding 500/uL or 5% of the peripheral blood white cells) at the time of screening.
- Inability to comply with protocol-mandated hospitalization and activities restrictions.
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- History of allogeneic stem cell transplant.
- Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
- Evidence of active mucosal or internal bleeding.
- Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety).
- Subjects with previous or concurrent malignancies are allowed only if the second tumor is not contributing to the subject's illness and deemed to be at negligible risk of metastasis or death (e.g., expected 5-year OS ≥90%). Examples include ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer (Gleason score ≤7) not requiring treatment or appropriately treated Stage I uterine cancer. Subjects must be appropriately observed or managed/controlled are permitted onto study. The subject must not be receiving active therapy, other than hormonal therapy for this disease and the disease must be considered medically stable for at least 2 years.
- Current corneal epithelial disease except mild punctate keratopathy.
- History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- Note that patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
- Patients with history of confirmed progressive multifocal leukoencephalopathy (PML).
- Prior solid organ transplantation.
- Treatment with radiotherapy (with the exception of local, palliative radiotherapy for management of pain or for stabilization of an extensive bone lesion at risk of pathologic fracture or damage to surrounding tissue), any chemotherapeutic agent, or treatment with systemic therapy (systemic or biologic agent) 14 days. Prior treatment with a monoclonal antibody within 28 days of receiving the first dose of study drug.
- Prior treatment with a monoclonal antibody, denosumab for hypercalcaemia is allowed.
- Use of an investigational drug within five half-lives or 28 days if the half-life of the investigational agent is unknown, preceding the first dose of study drug.
- Any major surgery within the last ≤ 4 weeks prior to initiating study treatment.
- Current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria.
- Evidence of cardiovascular risk including any of the following:
- Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobiz Type II) or 3rd degree atrioventricular (AV) block.
- QTc interval ≥ 470 msecs. NOTE: The QT interval should be corrected for the heart rate by Fridericia's formula (QTcF)
- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting or bypass grafting, all within 6 months of Screening.
- Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Uncontrolled hypertension
- Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM
- Note that patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed.
- Note that patients with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed.
- Significant active pulmonary disease (e.g., bronchospasm and/or obstructive pulmonary disease)
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belamaf and/or cevostamab any of the components of the study treatment. History of severe hypersensitivity to other mAbs.
- Known history of HLH/IEH-HS or macrophage activation syndrome (MAS).
- Prior treatment with systemic immunotherapeutic agents, including, but not limited to cytokine therapy and anti-CTLA4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first dose of study drugs.
- Active infection requiring antibiotic, antiviral, or antifungal treatment.
- Known HIV infection.
- Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
- Known or suspected chronic active Epstein-Bar Virus (EBV) infection. Guidelines for diagnosing chronic active EBV infection are provided by Okano et al. 2005.
- Presence of hepatitis B (HBV) surface antigen (HBsAg) or positive HBV PCR test at screening or within 3 months prior to first dose of study treatment. Participants with positive hepatitis B core antibody (HBcAb) can be enrolled, only if confirmatory negative Hepatitis B DNA is obtained AND patient is on hepatitis B prophylaxis (eg tenofovir or entecavir) before first dose of study drugs. Presence of isolated Hep B surface antigen (HBsAb) indicating previous vaccination will not exclude a participant.
- Positive hepatitis C (HCV) antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
- Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
- History of receiving systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), with the exception of corticosteroid treatment ≤10mg/day prednisone or equivalent within 2 weeks prior to first dose of study drugs.
- The use of inhaled corticosteroids is permitted
- The use of mineralocorticoids for management of orthostatic hypotension is permitted
- The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted however the dose should not exceed 10 mg prednisone a day.
- Intolerance to prednisone or dexamethasone that would preclude the patient from taking the full starting dose of dexamethasone or prednisone as described in the protocol.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Heather Hiscock, MSc, 416- 477-9849 ext. 205, cmrg@cmrg.ca
Steven Shih, MD
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Heather Hiscock, MSc, 416- 477-9849 ext. 205, cmrg@cmrg.ca
Curtis Marcoux, MD
London Health Sciences Centre
London, Ontario, N6A 5W9
Heather Hiscock, MSc, 416- 477-9849 ext. 205, cmrg@cmrg.ca
Martha Louzada, MD
Hospital Maisonneuve - Rosemont
Montreal, Quebec, H1T2M4
Heather Hiscock, MSc, 416- 477-9849 ext. 205, cmrg@cmrg.ca
Richard LeBlanc, MD
McGill University Health Centre -MUHC
Montreal, Quebec, H4A 3J1
Heather Hiscock, MSc, 416- 477-9849 ext. 205, cmrg@cmrg.ca
Michael Sebag, MD
The Ottawa Hospital - General Hospital
Ottawa, Ontario, K1H 8L6
Heather Hiscock, MSc, 416- 477-9849 ext. 205, cmrg@cmrg.ca
Arleigh McCurdy, MD
UHN-Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Heather Hiscock, MSc, 416- 477-9849 ext. 205, cmrg@cmrg.ca
Suzanne Trudel, MD
About this study
Official title: An Open-Label Phase Ib, Multicenter Study To Evaluate The Safety And Efficacy Of Belantamab Mafodotin Plus Cevostamab And Pomalidomide In Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
This study will evaluate efficacy and tolerability various doses of belantamab mafodotin in combination with cevostamab and pomalidomide in patients with multiple myeloma who have relapsed disease after two or more lines of therapy and/or have refractory to treatment disease.
Read the detailed description
This is a phase Ib, multicenter, open-label study to evaluate the safety and efficacy various doses of belantamab mafodotin (belamaf) in combination with cevostamab and pomalidomide in patients with relapsed and/or refractory multiple myeloma (RRMM). The study consists of 2 parts.
Part 1 will evaluate the clinical activity and safety of up to three dose combinations of belamaf and cevostamab in patients who have relapsed and refractory multiple myeloma after receiving 2 or more prior lines of therapy and having previously received lenalidomide, a proteosome inhibitor, and/or anti-CD38 mAb. Their disease must be refractory to the last line of therapy. The doses will be evaluated in cohorts: Cohort 1a - belamaf 1.9 mg/kg + cevostamab 90 mg; Cohort 1b - belamaf 1.9 mg/kg + cevostamab 160 mg; and Cohort 1c - belamaf 2.5 mg/kg + cevostamab 160 mg. In this part I the recommended phase 2 dose (RP2D) of the combination will be determined.
Part 2 will evaluate the clinical activity and safety of the recommended phase 2 dose (RP2D) in patients who have relapsed multiple myeloma having previously received 1-3 prior line of therapy including lenalidomide, a proteosome inhibitor, and/or an anti-CD38 mAb.
In addition, a cohort exploring the safety and efficacy of the combination of cevostamab and belamaf at the recommended phase 2 dose (RP2D) with low dose pomalidomide (2 mg ) will be considered.
This study will have an induction phase (cycle 1-6) and a maintenance phase (cycle 7 onwards). Participants will receive study treatment until progression is documented. Participants will be followed for up to 24 months after confirmation of progressive disease or until death, whichever is reached earlier.
- Being tested
- Belamaf, Cevostamab, Pomalidomide
- Keywords
- Multiple Myeloma Refractory, Multiple Myeloma Relapsed, belamaf, cevostamab, Belantamab Mafodotin, humanized IgG1 antibody-drug conjugate, humanized, full-length IgG1 anti-FcRH5/CD3, Relapsed/Refractory Multiple Myeloma, Myeloma, Multiple Myeloma, Blenrep
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelamafDrug
Also called Belantamab mafodotin, GSK2857916
Administered intravenously
CevostamabBiological
Also called BFCR4350A
Administered intravenously
PomalidomideDrug
Also called Pomalyst
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Belamaf + Cevostamab | Experimental | Belamaf + Cevostamab will be administrated on the dose escalation schedule in cycles: induction phase cycles are 21 days (Q3W) for 6 cycles followed by maintenance phase cycles, which are 42 days (Q6W). Up to 3 cohorts (Cohorts 1a-c) evaluating escalating doses of belamaf and cevostamab will be evaluated. (Cohort 1a - belamaf 1.9 mg/kg + cevostamab 90 mg; Cohort 1b - belamaf 1.9 mg/kg + cevostamab 160 mg; and Cohort 1c - belamaf 2.5 mg/kg + cevostamab 160 mg.) Treatment will continue until progression or unacceptable toxicity.
Then, after the recommended phase 2 dose (RP2D) is determined, Cohort 2 will receive Belamaf + Cevostamab at the RP2D schedule in cycles: induction phase cycles are 21 days (Q3W) for 6 cycles followed by maintenance phase cycles, which are 42 days (Q6W). Treatment will continue until progression or unacceptable toxicity. Receives: Drug: Belamaf; Biological: Cevostamab |
| Belamaf + Cevostamab+ Pomalidomide | Experimental | Belamaf + Cevostamab at RP2D with pomalidomide at 2 mg at 14/21 schedule in cycles: induction phase cycles are 21 days (Q3W) for 6 cycles followed by maintenance phase cycles, which are are 42 days (Q6W). pomalidomide on 14/21 schedule. Treatment will continue until progression or unacceptable toxicity. Receives: Drug: Belamaf; Biological: Cevostamab; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D)
The Recommended Phase 2 Dose (RP2D) will be determined based on the incidence of dose-limiting toxicities (DLTs), overall tolerability, and preliminary antitumor activity. DLTs will be evaluated based on adverse events, clinical assessments, and laboratory test results.
Measured: From the first dose of study drugs until the end of 3 cycles of therapy (up to 9 weeks; each cycle is 21 days) in the last dose-escalation cohort, or until study therapy is discontinued due to disease progression or toxicity, whichever occurs first.
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the proportion of participants who achieved a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to International Myeloma Working Group (IMWG) criteria.
Measured: From 3 weeks after the first dose of study therapy (end of Cycle 1; Cycle 1 is 21 days) until the date of documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Secondary outcomes (8)
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first.
Measured: From the date of the first dose of study therapy until the date of documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Duration of Response (DOR)
Duration of Response (DOR) is defined as the time from the date of first documented partial response (PR) or better until documented disease progression or death from any cause, whichever occurs first.
Measured: From the date of first documented partial response or better to the date of documented disease progression or death, whichever occurs first, assessed up to 24 months.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first dose of study treatment to death from any cause.
Measured: From the date of the first dose of therapy until the date of death from any cause, assessed up to 24 months.
Rates of Corneal Adverse Events
The proportion of participants experiencing corneal adverse events, including a decrease in best corrected visual acuity (>20/50) in both eyes at the same time, at the recommended dose of belamaf in combination with cevostamab.
Measured: From 1 day before receiving belamaf until the end of treatment or, if corneal findings are present, until corneal findings return to pre-treatment (baseline) condition or become stable, assessed up to 12 months.
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs)
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non- investigational) product, whether or not related to that medicinal (investigational) product. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that may require medical or surgical intervention, results in a second malignancy.
Measured: From 1 day before receiving study therapy until death from any cause or 90 days after discontinuation of study therapy, whichever occurs first.
Number of Adverse Events of Special Interest (AESI)
- Any grade ≥2 CRS (Cytokine Release Syndrome)
- Any suspected or confirmed HLH/IEC-HS (Hemophagocytic Lymphohistiocytosis/ Immune Effector Cell-Associated HLH-Like Syndrome)
- Any grade ICANS (Immune effector cell-associated neurotoxicity syndrome)
- Grade 4 Corneal AEs (Adverse Events)
- Grade ≥ 3 infections
- Grade ≥ 2 Infusion Related Reactions
Measured: From 1 day before receiving the study therapy until the date of death from any cause or 90 days following last date of study therapy, whichever occurs first.
Change from Baseline in Health-Related Quality of Life as Assessed by EORTC QLQ-C30
Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), a 30-item cancer-specific questionnaire.
Scores range from 0 to 100, with higher scores on the Global Health Status/Quality of Life scale indicating better health-related quality of life.
Measured: From 1 day before receiving study therapy to the end of study treatment, including the last day of treatment, assessed up to approximate 73 months.
Change From Baseline in Patient-Reported Outcomes as Assessed by PRO-CTCAE
Patient-reported outcomes will be assessed using selected Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to assess toxicities of interest, including neurological symptoms (numbness, tingling, dizziness) and visual symptoms (blurred vision, flashing lights, visual floaters and watery eyes).
Measured: From 1 day before receiving study therapy to the end of study treatment, including the last day of treatment, assessed up to approximate 73 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionJan 2033 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part 1 (Cohorts 1 a-c) consists of a dose optimization and safety run-in phase of up to 3 cohorts evaluating escalating doses of belamaf and cevostamab. Part 2, Cohort 2 will evaluate the clinical activity and safety of the RP2D. Part 2, Cohort 3 to evaluate the RP2D with pomalidomide will be considered.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Myeloma Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Suzanne Trudel, MD, Principal investigator, UHN-Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831122
- Sponsor's protocol ID
- CMRG 011
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No