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New treatment option for SMARCB1-Deficient Malignancies
Official title Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies
ClinicalTrials.gov ID: NCT06444880
What this study is testing
What is Ubamatamab?
Ubamatamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for smarcb1-deficient malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To find out if ubamatamab, given by itself or in combination with cemiplimab, can help to control the disease in participants with renal medullary carcinoma (RMC) and epithelioid sarcoma (ES).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Participants with locally advanced or metastatic RMC (RMC cohort) or ES (ES cohort) histologically confirmed by expert pathology review and loss of...
- Eligible participants should either demonstrate serum CA-125 levels ≥ 70 units/ml during screening or positive H score of \>25 for MUC16 (CA-125) by...
- The H score is calculated using the standard formula commonly used in IHC: H score = [(0 x % negative cells) + (1 x % weak positive cells) + (2 x %...
- If serum CA-125 ≥ 70 units/ml then participants will be enrolled without delay. IHC for MUC16 will be used as a correlative biomarker but not for...
- If serum CA-125 \< 70 units/ml then for trial eligibility, MUC16 expression should be checked by IHC in tumor tissues collected within 12 months from...
You likely can't join if
- Participants must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without...
- Participants previously treated with T-cell-redirecting bispecific antibodies or MUC16-targeted therapies (including vaccines) are excluded...
- Participants currently receiving anticancer therapies or who have received anticancer therapies (including chemotherapy and targeted therapies such...
- Participants with persistent grade ≥2 adverse events from prior systemic therapies that would confound timely detection of immune-related adverse...
- Participants, who have had a major surgery or significant traumatic injury (injury requiring \> 4 weeks (28 days) to heal) within 4 weeks (28 days)...
- Participants who have organ allografts.
See the full eligibility criteria
Who can join
- Participants with locally advanced or metastatic RMC (RMC cohort) or ES (ES cohort) histologically confirmed by expert pathology review and loss of SMARCB1 staining by IHC. Participants with advanced or metastatic...
- Eligible participants should either demonstrate serum CA-125 levels ≥ 70 units/ml during screening or positive H score of \>25 for MUC16 (CA-125) by IHC in tumor tissues collected within 12 months from screening as...
- The H score is calculated using the standard formula commonly used in IHC: H score = [(0 x % negative cells) + (1 x % weak positive cells) + (2 x % moderate positive cells) + (3 x % strong positive cells). For instance...
- If serum CA-125 ≥ 70 units/ml then participants will be enrolled without delay. IHC for MUC16 will be used as a correlative biomarker but not for trial eligibility.
- If serum CA-125 \< 70 units/ml then for trial eligibility, MUC16 expression should be checked by IHC in tumor tissues collected within 12 months from screening: i. If H score is \< 25 then the patient will not be...
- Participants will be eligible in the RMC cohort regardless of whether they have had prior nephrectomy or still have their primary tumor in-situ.
- Participants must have at least one measurable site of disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures ≥ 15 mm with conventional...
- Participants must have progressed on at least one line of prior therapy.
- There must be evidence of progression on or after last treatment regimen received.
- ECOG performance status 0-1 a. NOTE: If participant is unable to walk due to paralysis, but is mobile in a wheelchair, participant is considered to be ambulatory for the purpose of assessing their performance status.
- Age (at the time of consent/assent): ≥ 18 years a. RMC is the third most common renal cell carcinoma in children and young adults in the United States21 and while we will initially enroll participants aged ≥18 years...
- Consent to MD Anderson companion laboratory protocol 2014-0938
- Participants must have adequate organ and marrow function as defined below: Hemoglobina ≥ 9 g/dl (treatment allowed) Absolute neutrophil countb ≥ 1,000/µL Platelets ≥ 75,000/µL Total bilirubin ≤ 1.5 mg/dl AST(SGOT) or...
- Participants with controlled brain metastases are allowed on protocol if the brain metastases were surgically resected or treated with radiosurgery or Gamma knife, without recurrence or edema for 1 month (4 weeks)...
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of the study drug.
- Women must not be breastfeeding.
- WOCBP must agree to follow instructions for method(s) of contraception from the time of registration for treatment for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 30 days...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Participants must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix...
- Participants previously treated with T-cell-redirecting bispecific antibodies or MUC16-targeted therapies (including vaccines) are excluded. Participants who received CAR-T therapies within 30 days of first dose of...
- Participants currently receiving anticancer therapies or who have received anticancer therapies (including chemotherapy and targeted therapies such as tazemetostat) within 2 weeks (14 days) prior to study Day 1 are...
- Participants with persistent grade ≥2 adverse events from prior systemic therapies that would confound timely detection of immune-related adverse events due to ubamatamab and/or cemiplimab or otherwise hinder patient...
- Participants, who have had a major surgery or significant traumatic injury (injury requiring \> 4 weeks (28 days) to heal) within 4 weeks (28 days) of start of study drug, participants who have not recovered from the...
- Participants who have organ allografts.
- Known or suspected autoimmune disease. Participants with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic...
- Uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency.
- Participants with HIV who have controlled infection (undetectable viral load with the exception of clinically insignificant blips and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are...
- Participants with hepatitis B surface antigen positive (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving antiviral therapy for hepatitis B) are...
- Participants with HBsAg negative but total HBV core antibody positive (HBc Ab+) are permitted with the following requirements: Serum HBV DNA PCR should be tested and if it is above the limit of detection at screening...
- Participants who are Hepatitis C virus antibody positive (HCV Ab +) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are...
- Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with...
- Participants must not be scheduled to receive another experimental drug while on this study.
- Participants who are on high dose steroid (e.g., \> 10mg prednisone daily or equivalent) or other more potent immune suppression medications (e.g., infliximab). Topical, inhaled, intra-articular, ocular, or intranasal...
- Left ventricular ejection fraction (LVEF) assessment with documented LVEF \< 50% by transthoracic echocardiogram (TTE) within 6 months prior to start of study treatment. In cases of LVEF 45-50% in absence of clinical...
- Active myocarditis, regardless of etiology.
- Moderate to large pericardial effusion (eg, \> approximately 100 mL) as measured by echocardiogram at baseline. Multigated acquisition (MUGA) is not sufficient for evaluating pericardial effusion.
- Has a history of any clinically significant arrhythmia including atrial fibrillation or implantation of a pacemaker or defibrillator.
- Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
- Symptomatic congestive heart failure of New York heart Association Class III or IV
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
- Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics or other...
- Participants with a history of major psychiatric illness judged unable to fully understand the investigational nature of the study and the risks associated with the therapy.
- Participants must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the...
- Participants should not receive immunization with attenuated live vaccines within 30 days of planned start of study medication. a. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines...
- Female participants who are pregnant or breast feeding, or adults of reproductive potential who are not willing to use effective birth control methods as defined above.
- Any participants who cannot be compliant with the appointments required in this protocol must not be enrolled in this study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ubamatamab or cemiplimab.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.