Ovarian CancerPhase 1/2NCT04590326
A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
A Phase 1/2 study testing REGN5668, Cemiplimab and Ubamatamab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Regeneron Pharmaceuticals at 28 sites in 5 countries.
Trial summary
This study is researching an investigational drug called REGN5668 : alone or, combined with cemiplimab (also known as REGN2810) or, combined with both cemiplimab and fianlimab (also known as REGN3767), or combined with ubamatamab (also known as REGN4018), with or without sarilumab. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- REGN5668, Cemiplimab and Ubamatamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 28 sitesin 5 countries
- Study dates
- 8 Dec 2020to 8 Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol
- Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.
- Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)
- Has adequate organ and bone marrow function as defined in the protocol
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of at least 3 months
- Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol
Who cannot join
- Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy
- Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol
- Prior treatment with a Mucin 16 (MUC16)-targeted therapy
- Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy
- Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug
- Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
Show all 10Show fewer
- Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
- Has history of clinically significant cardiovascular disease as defined in the protocol
- Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s).
- Note: Other protocol-defined Inclusion/Exclusion criteria apply
Trial locations and contacts
28 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 5 countries
United States13 sites, 12 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Dana Farber Cancer Institute Brookline Avenue
Boston, Massachusetts, 02215
- Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
- Recruiting
The City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Chao Family Comprehensive Cancer Center
Orange, California, 92868
- Recruiting
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Seattle Cancer Care Alliance at South Lake Union - G3630
Seattle, Washington, 98109
- Completed
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
France5 sites, 5 recruiting
- Recruiting
Institut Bergonie
Bordeaux, New Aquitaine, 33076
- Recruiting
Centre Francois Baclesse (CFB)
Caen, Normandy, 14076
- Recruiting
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, 21000
- Recruiting
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône, 69310
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Spain5 sites, 5 recruiting
- Recruiting
Institut Catala dOncologia Girona
Girona, 17007
- Recruiting
Ciudad Universitaria
Madrid, 28040
- Recruiting
Hospital Universitario Fundacion Jimenez
Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
Madrid, 28041
- Recruiting
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, 15706
Brazil4 sites, 4 recruiting
- Recruiting
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
- Recruiting
Centro de Pesquisa em Oncologia PUCRS
Porto Alegre, Rio Grande do Sul, 90619-900
- Recruiting
AC Camargo Cancer Center, Fundacao Antonio Prudente
São Paulo, 01509-010
- Recruiting
Unimed Sorocaba
Sorocaba, São Paulo, 18065-100
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies
This study is researching an investigational drug called REGN5668 :
- alone or,
- combined with cemiplimab (also known as REGN2810) or,
- combined with both cemiplimab and fianlimab (also known as REGN3767), or
- combined with ubamatamab (also known as REGN4018), with or without sarilumab.
Read more
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 participants with ovarian cancer or cancer of the uterus
- Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus
This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2.
The study is looking at several other research questions, including:
- Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab
- How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab
- How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood
- To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer
- Being tested
- REGN5668, Cemiplimab, Ubamatamab, Sarilumab, Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
- Keywords
- Progressive, Recurrent, Refractory, Serum CA-125 levels >= 2x ULN
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Endometrial Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN5668Drug
Also called ubletamig
Administer per the protocol
CemiplimabDrug
Also called REGN2810, Libtayo®
Administer per the protocol
UbamatamabDrug
Also called REGN4018
Administer per the protocol
SarilumabDrug
Also called Kevzara®
Administer per the protocol
Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]Drug
Administer per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Module 1 | Experimental | REGN5668 in combination with cemiplimab, or cemiplimab + fianlimab Receives: Drug: REGN5668; Drug: Cemiplimab; Drug: Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)] |
| Module 2 | Experimental | REGN5668 and ubamatamab Receives: Drug: REGN5668; Drug: Ubamatamab; Drug: Sarilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLT)
Dose escalation phase, Module 1
Measured: 42 days
Incidence of DLTs
Dose escalation phase, Module 2
Measured: 21 days post combination administration
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Primary: Dose escalation phase Secondary: Dose expansion phase
Measured: Through study completion, up to 5 years
Incidence of Serious Adverse Events (SAEs)
Primary: Dose escalation phase Secondary: Dose expansion phase
Measured: Through study completion, up to 5 years
Incidence of deaths
Primary: Dose escalation phase Secondary: Dose expansion phase
Measured: Through study completion, up to 5 years
Incidence of laboratory abnormalities (Grade 3 or higher per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0 [v5.0])
Primary: Dose escalation phase Secondary: Dose expansion phase
Measured: Through study completion, up to 5 years
Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or ubamatamab
Primary: Dose escalation phase
Measured: Through study completion, up to 5 years
Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Eisenhauer, 2009) of REGN5668 in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination)
Primary: Dose expansion phase
Measured: Through study completion, up to 5 years
Secondary outcomes (11)
ORR based on RECIST 1.1
Dose escalation phase
Measured: Through study completion, up to 5 years
Best Overall Response (BOR) based on RECIST 1.1
Dose escalation and expansion phases
Measured: Through study completion, up to 5 years
Duration Of Response (DOR) based on RECIST 1.1
Dose escalation and expansion phases
Measured: Through study completion, up to 5 years
Disease Control Rate (DCR) based on RECIST 1.1
Dose escalation and expansion phases
Measured: Through study completion, up to 5 years
Progression-Free Survival (PFS) based on RECIST 1.1
Dose escalation and expansion phases
Measured: Through study completion, up to 5 years
Cancer Antigen 125 (CA-125) change from baseline after treatment with REGN5668 in combinations with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination)
Dose escalation and expansion phases
Measured: Through study completion, up to 5 years
Concentration of REGN5668 in serum over time when dosed alone and in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab
Dose escalation and expansion phases
Measured: Through study completion, up to 5 years
Presence or absence of anti-drug antibodies against REGN5668
Dose escalation and expansion phases
Measured: Through study completion, up to 5 years
Presence or absence of anti-drug antibodies against ubamatamab
Dose escalation and expansion phases
Measured: Through study completion, up to 5 years
Presence or absence of anti-drug antibodies against cemiplimab
Dose escalation and expansion phases
Measured: Through study completion, up to 5 years
Presence or absence of anti-drug antibodies against fianlimab
Dose escalation and expansion phases
Measured: Through study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start8 Dec 2020
- Primary completion8 Nov 2028 (estimated)
- Study completion8 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590326
- Sponsor's protocol ID
- R5668-ONC-1938
- Other IDs
- 2022-501904-83-00
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2020
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies
- ClinicalTrials.gov ID
- NCT04590326
- Acronym / sponsor ID
- R5668-ONC-1938
- Keywords
- Progressive, Recurrent, Refractory, Serum CA-125 levels >= 2x ULN
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 8 Nov 2028 (estimated)
- Study completion
- 8 Nov 2028 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is researching an investigational drug called REGN5668 :
- alone or,
- combined with cemiplimab (also known as REGN2810) or,
- combined with both cemiplimab and fianlimab (also known as REGN3767), or
- combined with ubamatamab (also known as REGN4018), with or without sarilumab.
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 participants with ovarian cancer or cancer of the uterus
- Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus
This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2.
The study is looking at several other research questions, including:
- Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab
- How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab
- How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood
- To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Module 1 | Experimental | Drug: REGN5668, Drug: Cemiplimab, Drug: Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]REGN5668 in combination with cemiplimab, or cemiplimab + fianlimab |
| Module 2 | Experimental | Drug: REGN5668, Drug: Ubamatamab, Drug: SarilumabREGN5668 and ubamatamab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol
- Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.
- Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)
- Has adequate organ and bone marrow function as defined in the protocol
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (10 listed)
- Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy
- Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol
- Prior treatment with a Mucin 16 (MUC16)-targeted therapy
- Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy
- Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN5668Also: ubletamigAdminister per the protocol | Drug | Module 1, Module 2 |
| CemiplimabAlso: REGN2810, Libtayo®Administer per the protocol | Drug | Module 1 |
| UbamatamabAlso: REGN4018Administer per the protocol | Drug | Module 2 |
| SarilumabAlso: Kevzara®Administer per the protocol | Drug | Module 2 |
| Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]Administer per the protocol | Drug | Module 1 |
Primary outcome
Incidence of Dose Limiting Toxicities (DLT)
Time frame: 42 days
Dose escalation phase, Module 1
Incidence of DLTs
Time frame: 21 days post combination administration
Dose escalation phase, Module 2
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
Incidence of Serious Adverse Events (SAEs)
Time frame: Through study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
Incidence of deaths
Time frame: Through study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
Incidence of laboratory abnormalities (Grade 3 or higher per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0 [v5.0])
Time frame: Through study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or ubamatamab
Time frame: Through study completion, up to 5 years
Primary: Dose escalation phase
Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Eisenhauer, 2009) of REGN5668 in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination)
Time frame: Through study completion, up to 5 years
Primary: Dose expansion phase
11 secondary outcomes
ORR based on RECIST 1.1
Time frame: Through study completion, up to 5 years
Best Overall Response (BOR) based on RECIST 1.1
Time frame: Through study completion, up to 5 years
Duration Of Response (DOR) based on RECIST 1.1
Time frame: Through study completion, up to 5 years
Disease Control Rate (DCR) based on RECIST 1.1
Time frame: Through study completion, up to 5 years
Progression-Free Survival (PFS) based on RECIST 1.1
Time frame: Through study completion, up to 5 years
Cancer Antigen 125 (CA-125) change from baseline after treatment with REGN5668 in combinations with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination)
Time frame: Through study completion, up to 5 years
Concentration of REGN5668 in serum over time when dosed alone and in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab
Time frame: Through study completion, up to 5 years
Presence or absence of anti-drug antibodies against REGN5668
Time frame: Through study completion, up to 5 years
Presence or absence of anti-drug antibodies against ubamatamab
Time frame: Through study completion, up to 5 years
Presence or absence of anti-drug antibodies against cemiplimab
Time frame: Through study completion, up to 5 years
Presence or absence of anti-drug antibodies against fianlimab
Time frame: Through study completion, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing REGN5668, Cemiplimab and Ubamatamab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Regeneron Pharmaceuticals at 28 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, France, Spain, Brazil, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities (DLT) (time frame: 42 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.