A Study of Sacituzumab Govitecan in People With Mesothelioma
Phase 2 Study of Sacituzumab Govitecan-hziy in Patients With Previously Treated Mesothelioma
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests sacituzumab govitecan in adults with pleural mesothelioma, a cancer in the lining around the lungs, who have already had treatment. Treatment continues until the cancer gets worse, side effects are too severe, or the patient or study doctor decides it is best to stop.
Participants will receive sacituzumab govitecan until their disease gets worse (progresses), they have severe side effects and cannot continue study treatment, or the participants or the study doctor thinks it's in your best interest to stop treatment.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older. You or your legal representative must agree in writing to join.
- Have diffuse pleural mesothelioma confirmed by a tissue test.
- Have had at least one treatment that works throughout the body, such as platinum/pemetrexed chemotherapy, immune treatment, or both.
- Have cancer that can be measured using the study’s rules.
- Agree to have tissue samples taken before treatment and before the third treatment cycle, if safe and possible.
- Meet the study’s activity and self-care score requirements.
- Have blood cell counts and kidney and liver function that meet the study’s limits.
- If you can become pregnant, use highly effective birth control for at least 1 month before treatment, during treatment, and for 2 months afterward.
Who can't join
- Be receiving another study treatment, or have used an experimental drug or device within 3 weeks before starting. Recent chemotherapy or immune treatment, or lasting serious side effects from past treatment, may also prevent joining.
- Have had an allergic reaction to irinotecan or any ingredient in sacituzumab govitecan.
- Have a mental health or substance use disorder that the study doctor believes would prevent you from following study requirements.
- Have another cancer that is growing or needs treatment. Certain treated skin, early prostate, and early cervical cancers are allowed.
- Have positive hepatitis B or C tests. Some people with past or treated infection, or a hepatitis B test affected by recent vaccination, may qualify under special rules.
- Have HIV with certain issues, such as medicines that interfere with study treatment, low immune cell counts, a recent AIDS-related infection, or not meeting HIV treatment and virus-level requirements.
- Have had certain heart or blood vessel problems within 6 months, including a heart attack, stroke, mini-stroke, unstable chest pain, or bypass surgery. Severe heart failure or a recent hospital stay for heart failure also prevents joining.
- Be pregnant or breastfeeding, or not follow the required birth control rules. When pregnancy is possible, male and female participants must use highly effective birth control during the study and for at least 60 days after the last treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Patient, or legally authorized representative (LAR), willing and able to provide written informed consent for the trial * Patient age ≥ 18 at time of consent * Pathologically confirmed diffuse pleural mesothelioma * Must have received at least one prior systemic therapy (platinum/pemetrexed, immunotherapy or a combination thereof) * Measurable disease as defined primarily by the modified RECIST criteria for mesothelioma (at PI discretion RECIST v1.1 may be used) * Consent to undergo a biopsy prior to Cycle 1 Day 1 and Cycle 3 Day 1 if deemed medically safe and feasible * Eastern Cooperative Oncology Group (ECOG) score 0 or Karnofsky Performance Status ≥ 70% * Adequate organ function, defined as * Absolute neutrophil count ≥ 1.5K/mcL * Platelet count ≥ 100K/mcL * Adequate renal function defined as creatinine clearance ≥ 30ml/min (as calculated by Cockcroft-Gault Formula) * Hemoglobin \> 9g/dL (prior transfusion permitted if not within 7 days of enrollment) * Total bilirubin ≤1.5 x upper limit of normal (ULN) if no liver metastases or \<3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits * AST, ALT ≤ 2.5 x ULN (if liver metastases are present, ≤5 × ULN) * If of childbearing potential, must be willing to use highly effective mode of contraception for at least one month prior, during, and for 2 months after the end of active therapy Exclusion Criteria: * Currently participating in another study and receiving another study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment * Prior hypersensitivity to irinotecan or any components of sacituzumab govitecan-hziy * Prior cytotoxic/immunologic systemic therapy within 3 weeks prior to study Day 1 or has not recovered (i.e., CTCAE v5 ≥ Grade 1 at baseline; from clinically significant adverse events due to a previously administered agent (excluding Grade 2 neuropathy) * Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial within the opinion of the investigator * Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early stage prostate cancer, or in situ cervical cancer after definitive treatment * Positive hepatitis B (hepatitis B virus \[HBV\]) surface antigen (HBsAg) o NOTE: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Patients who fit these criteria must use Hep B prophylaxis during treatment. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing * Positive hepatitis C antibody (anti-HCV) o NOTE: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible * Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following: * Receiving ART that may interfere with study treatment (consult sponsor for review of medication prior to enrollment) * CD4 count \< 350 cells/mm3 at screening * AIDS-defining opportunistic infection within 6 months of start of screening * Not agreeing to start ART and be on ART \> 4 weeks plus having HIV viral load \<400 copies/mL at end of 4-week period (to ensure ART is tolerated and HIV controlled) * Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or coronary/peripheral artery bypass graft, or any acute coronary syndrome within 6 months of start of study drug * Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of study Day 1 * Pregnant women or women who are breastfeeding or of childbearing potential and not using a highly effective method of birth control for at least one month prior to enrollment. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 60 days after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent)
Study sites (7)
NJ
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, NJ 07920Michael Offin, MD · Study contact · 646-449-1778More trials in Basking Ridge
- Memorial Sloan Kettering Monmouth · Middletown, NJ 07748Michael Offin, MD · Study contact · 646-608-3763More trials in Middletown
- Memorial Sloan Kettering Bergen · Montvale, NJ 07645Michael Offin, MD · Study contact · 646-608-3763More trials in Montvale
NY
- Memorial Sloan Kettering Cancer Center @ Commack · Commack, NY 11725Michael Offin, MD · Study contact · 646-608-3763More trials in Commack
- Memorial Sloan Kettering Westchester · Harrison, NY 10604Michael Offin, MD · Study contact · 646-608-3763More trials in Harrison
- Memorial Sloan - Kettering Cancer Center · New York, NY 10021Michael Offin, MD · Study contact · 646-608-3763More trials in New York
- Memorial Sloan Kettering Nassau · Uniondale, NY 11553Michael Offin, MD · Study contact · 646-608-3763More trials in Uniondale