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REGN4018

A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

Open
Grade
High grade, Low grade
Prior lines
1, 2, 3, 4
Histology
Serous, Endometrioid Clear-cell Mucinous Other (bv. mixed/rare)
Platin
Platinum sensitive
Platinum resistant
Primary platinum refractory
Secondary platinum refractory
Phase
I/II
IMP
REGN4018, Cemiplimab
principal investigator
Prof. Els Van Nieuwenhuysen

Treatment

This trial consists of two different treatment options:

  • REGN4018
  • REGN4018 + Cemiplimab

REGN4018 is a MUC16xCD3 bispecific antibody.
Both REGN4018 and Cemiplimab are administered intravenously.

Patients are assigned to one of either group based on their disease characteristics and the availability of slots. 
No randomisation will be performed.

Treatment duration

The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent

Eligibility

Main inclusion criteria:

  • Diagnosis of advanced, epithelial ovarian cancer (except carcino-sarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:
    • Serum CA-125 level ≥2x upper limit or normal (ULN) (in screening) 
    • Has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts) 
    • Documented relapse or progression on or after the most recent line of therapy 
    • No standard treatment options likely to convey clinical benefit
  • Adequate organ and bone marrow function as defined in the protocol
  • Life expectancy of at least 3 months
  • Randomized phase 2 expansion cohort: Platinum-resistant ovarian cancer patients who have had 1 to 3 lines of Platinum-based therapy as defined in the protocol

Main exclusion criteria:

  • Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
  • More than 4 prior lines of cytotoxic chemotherapy
  • Prior treatment with a MUC16-targeted therapy
  • Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol
  • History and/or current cardiovascular disease, as defined in the protocol
  • Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT03564340). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.

Contact

In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be

More information on this trial (NCT03564340)