Cancer Type: Gynecological Tumor
Study Type: Treatment
Phase: Phase I/II
Principal Investigator: Wenham, Robert
Phase I/II Study of REGN5668 (MUC16 x CD28, A Costimulatory Bispecific) Administered In Combination With Cemiplimab or REGN4018 (MUC16 x CD3)
The main purposes of this study are to: Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to patients with ovarian cancer; Look for signs that the study drugs can treat ovarian cancer
Primary Objective: The primary objectives of the study are: In the Dose Escalation Phase: -To assess the safety, tolerability, and pharmacokinetics (PK) of REGN5668 alone and in separate combinations with cemiplimab or REGN4018, in order to determine a maximally tolerated dose(s) (MTD) or recommended phase 2 dose(s) (RP2D) these combinations. In the Dose Expansion Phase: -To assess the preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018, (separately by cohort and combination) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Secondary Objectives: The secondary objectives of the study are: In the Dose Escalation Phase: -To assess the preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) as determined by ORR by RECIST 1.1 In the Dose Expansion Phase: -To characterize the safety profile in each expansion cohort -To characterize the PK of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) In both the Dose Escalation and Dose Expansion Phases: -To assess preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018 (separated by cohort and combination) as measured by ORR based on immune based therapy (iRECIST), best overall response (BOR), duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS) based on RECIST 1.1 and iRECIST -To assess changes in CA-125 levels from baseline after treatment with REGN5668 in combinations with cemiplimab or REGN4018 (separately by cohort and combination) -Immunogenicity of REGN5668, alone and in combinations with cemiplimab or REGN4018 Exploratory Objectives: The exploratory objectives of the study are: -To evaluate biomarkers that may correlate with mechanism of action, increased understanding of disease/on-target activity, observed toxicity, and potential anti-tumor activity, or markers that may be predictors of efficacy and/or safety, which may include but are not limited to: -MUC16 and programmed cell death-ligand 1 (PD-L1) expression in tumors -Intratumoral and circulating immune cell populations -Plasma cytokine, chemokines and other circulating proteins -Intratumoral gene/transcript expression, tumor and circulating gene mutational burden -Where possible, to evaluate the relationship between exposure and efficacy, biomarker and safety endpoints -To assess overall survival (OS)
Cell Therapy; Immunotherapy; Therapy (NOS)
Cemiplimab (); REGN2810 (Cemiplimab); REGN4018 (); REGN5668 ()
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
Back to top
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.
Moffitt Cancer Center is committed to the health and safety of our patients and their families. For more information on how we’re protecting our new and existing patients, visit our COVID-19 Info Hub
A secure website for patients to access their medical care at Moffitt.
An online resource for referring physicians and their staff.
For Moffitt faculty & staff members to access MoffittNet applications.
Our patient services specialists can assist you with scheduling an appointment, questions about medical records, insurance, billing and more.
Patient Appointment Center Hours: 7 a.m. to 7 p.m. Monday - Friday; 8 a.m. to noon Saturday