RecruitingPhase 1/2

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

United States890 participantsStarted 2018-05-21

Plain-language summary

The main purpose of this study is to: * Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus * The study will also look at the levels of ubamatamab and/or cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics * The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)
✓. 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 therapy 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 (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.

Exclusion criteria

What they're measuring

Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy

Timeframe: From Cycle 1, Day 1 up to 35 days

Number of participants with DLTs for ubamatamab with cemiplimab

Timeframe: From Cycle 2, Day 1 up to 21 days

Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for ubamatamab monotherapy

Timeframe: Up to 2 years

Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab

Timeframe: Up to 2 years

Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy

Timeframe: Up to 2 years

Number of participants with SAEs for ubamatamab with cemiplimab

Timeframe: Up to 2 years

Number of deaths for ubamatamab monotherapy

Timeframe: Up to 2 years

Number of deaths for ubamatamab with cemiplimab

Trial details

NCT IDNCT03564340

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-10

Contact for this trial

Clinical Trials Administrator

844-734-6643 clinicaltrials@regeneron.com

View on ClinicalTrials.gov More Recurrent Ovarian Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)
✓. 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 therapy 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 (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.

Exclusion criteria

What they're measuring

Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy

Timeframe: From Cycle 1, Day 1 up to 35 days

Number of participants with DLTs for ubamatamab with cemiplimab

Timeframe: From Cycle 2, Day 1 up to 21 days

Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for ubamatamab monotherapy

Timeframe: Up to 2 years

Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab

Timeframe: Up to 2 years

Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy

Timeframe: Up to 2 years

Number of participants with SAEs for ubamatamab with cemiplimab

Timeframe: Up to 2 years

Number of deaths for ubamatamab monotherapy

Timeframe: Up to 2 years

Number of deaths for ubamatamab with cemiplimab