Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

Overview

Información sobre este estudio

Primary Objectives In the Dose Escalation Phase:

To assess the safety and pharmacokinetics (PK) in order to determine a maximally tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimab.

In the Dose Expansion Phase:

To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab, (separately by cohort) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Secondary Objectives In the Dose Escalation Phase:

To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) 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 REGN4018 as monotherapy and in combination with cemiplimab.
To assess the effects of REGN4018 as monotherapy and in combination with cemiplimab on patient-reported outcomes (PROs), including health-related quality of life (HRQoL), functioning, and symptoms.

In both the Dose Escalation and Dose Expansion Phases:

To assess preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as measured by ORR based on iRECIST, best overall response (BOR), duration of response (DOR), disease control rate, complete response (CR) rate and progression-free survival (PFS) based on RECIST 1.1 and iRECIST.
To assess efficacy of REGN4018 as monotherapy and in combination with cemiplimab as measured by CA-125 level.
Immunogenicity of REGN4018 and cemiplimab.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Key Inclusion Criteria:

1. Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed
diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary
peritoneal, or fallopian tube cancer who have all of the following:

1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening)

2. 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)

3. documented relapse or progression on or after the most recent line of therapy

4. no standard therapy options likely to convey clinical benefit

2. Adequate organ and bone marrow function as defined in the protocol

3. Life expectancy of at least 3 months

4. Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian
cancer patients who have had 1 to 3 lines of platinum-based therapy as defined in the
protocol.

5. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has
progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy
and platinum-based chemotherapy:

1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC)

2. 1-2 prior lines of systemic therapy

Key Exclusion Criteria:

1. Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in
the protocol

2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic
chemotherapy

3. Prior treatment with a MUC16 - targeted therapy

4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or
spinal cord compression, as described in the protocol

5. History and/or current cardiac findings as defined in the protocol

6. Severe and/or uncontrolled hypertension at screening. Patients taking
anti-hypertensive medication must be on a stable anti-hypertensive regimen

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/15/2024. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic	Estatus	Contacto
Rochester, Minn. Investigador principal de Mayo Clinic Matthew Block, M.D., Ph.D.	Abierto para la inscripción	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Sede de Mayo Clinic

Estatus

Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Matthew Block, M.D., Ph.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Ensayos clínicos