A Study of Sacituzumab Govitecan in People With Mesothelioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Sacituzumab govitecan-hziy
DrugAfter enrollment, participants will receive SG until disease progression or intolerable toxicity.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Participants with MesotheliomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate
Clinical efficacy of SG in participants with recurrent and/or unresectable/metastatic DPM treated past the Cycle 3 tumor assessment determined by overall response rate as primarily assessed by modified (m)RECIST. Overall response rate defined as participants who achieve complete response or partial response as best overall response by modified RECIST v1.1 criteria for mesothelioma.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov