Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial Cancer

October 29, 2026 updated by: Pfizer

AN INTERVENTIONAL PHASE 3, OPEN LABEL, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH ADVANCED OR RECURRENT MISMATCH REPAIR PROFICIENT ENDOMETRIAL CANCER

This study is being conducted to assess whether the study medicine PF 08634404, given in combination with chemotherapy, improves outcomes compared with another medicine called pembrolizumab plus chemotherapy. Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing.

Our bodies have a built-in DNA "spell-checker," called the mismatch repair (MMR) system, that fixes genetic mistakes. In most endometrial cancers, this system works normally, and these cancers are called MMR-proficient (pMMR). However, pMMR tumors are harder for the immune system to recognize and attack. When endometrial cancer has spread beyond the uterus or comes back after previous treatment, it is called advanced or recurrent endometrial cancer. This study is for adults with mismatch repair-pMMR advanced or recurrent endometrial cancer.

Participants must meet key criteria, including:

  • Women who are 18 years or older, and not pregnant at the time of joining the study
  • pMMR endometrial cancer only
  • Measurable Stage III disease, Stage IV disease (with or without measurable disease) per FIGO staging, a system doctors use to describe how far cancer has spread in the body, or recurrent (with or without measurable disease) endometrial cancer
  • Has not received chemotherapy except for chemotherapy given after the main surgery and more than 6 months before relapse
  • Be in good enough health to receive study treatment. Approximately 600 adult women will be enrolled. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups, with about half in each group. The study is open, meaning both the doctors and participants know what treatment is being given. Participants will receive their assigned treatment through intravenous infusions (medicine is given directly into a vein). The treatment will be given in cycles.

Experimental Group will receive new study medicine called PF-08634404 plus chemotherapy. It will be followed by PF 08634404 alone for up to 2 years (35 cycles).

Control Group will receive an approved medicine called pembrolizumab plus chemotherapy. It will be followed by pembrolizumab alone for up to 2 years (20 cycles).

The study will include regular visits for:

  • Participants will have regular visits to the study site for treatment, health checks, and tests.
  • After stopping treatment, participants will come for a final visit within a month to check their health and review any reactions.
  • Follow-up will continue every 12 weeks by phone or in person or by reviewing health records. This helps check health and any new treatments.
  • Tests will be done every 9 weeks during the first 104 weeks to see how the cancer is responding. After that, tests will be done every 12 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Not yet recruiting
        • GenesisCare - Campbelltown
    • Queensland
      • Toowoomba, Queensland, Australia, 4350
        • Not yet recruiting
        • Toowoomba Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Not yet recruiting
        • Bayside Health - Peninsula University Hospital
  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
  • Japan
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital
      • Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0061
        • Recruiting
        • Sapporo Medical University Hospital
    • Hyōgo
      • Akashi, Hyōgo, Japan, 673-8558
        • Recruiting
        • Hyogo Cancer Center
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Not yet recruiting
        • Saitama Medical University International Medical Center
    • Tokyo
      • Koto-ku, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR
  • Taiwan
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 404332
        • Not yet recruiting
        • China Medical University Hospital
  • United States
    • Florida
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Jupiter Medical Center/ Anderson Family Cancer Institute
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Orlando Regional Medical Center
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Winnie Palmer Hospital for Women & Babies
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Ambulatory Care Center
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Minnesota Oncology Hematology, PA
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Minnesota Oncology Hematology, PA
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Minnesota Oncology Hematology, PA
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology, PA
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology, PA
    • Nevada
      • Reno, Nevada, United States, 89511
        • Recruiting
        • The Center of Hope
    • New York
      • Albany, New York, United States, 12206
        • Not yet recruiting
        • New York Oncology Hematology
      • White Plains, New York, United States, 10601
        • Recruiting
        • White Plains Hospital
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
    • Oregon
      • Happy Valley, Oregon, United States, 97015
        • Recruiting
        • Northwest Cancer Specialists, P.C.
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Northwest Cancer Specialists, P.C.
      • Tigard, Oregon, United States, 97223
        • Recruiting
        • Northwest Cancer Specialists, P.C.
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute- Pharmacy
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Texas Oncology - West Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Texas Oncology-West Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Oncology - Central South
      • Austin, Texas, United States, 78758
        • Recruiting
        • Texas Oncology - Central South
      • Austin, Texas, United States, 78745
        • Recruiting
        • Texas Oncology - Central South
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Texas Oncology-West Texas
      • El Paso, Texas, United States, 79915
        • Recruiting
        • Texas Oncology - West Texas
      • El Paso, Texas, United States, 79938
        • Recruiting
        • Texas Oncology - West Texas
      • Harlingen, Texas, United States, 78550
        • Recruiting
        • Texas Oncology - Central South
      • Irving, Texas, United States, 75063
        • Recruiting
        • US Oncology Investigational Products Center (IPC)
      • McAllen, Texas, United States, 78503
        • Recruiting
        • Texas Oncology - Central South
      • Midland, Texas, United States, 79701
        • Recruiting
        • Texas Oncology-West Texas
      • Odessa, Texas, United States, 79761
        • Recruiting
        • Texas Oncology - West Texas
      • Waco, Texas, United States, 76712
        • Recruiting
        • Texas Oncology - Central South
      • Weslaco, Texas, United States, 78596
        • Recruiting
        • Texas Oncology - Central South
      • Wichita Falls, Texas, United States, 76310
        • Recruiting
        • Texas Oncology-West Texas
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Recruiting
        • Virginia Oncology Associates
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • Virginia Oncology Associates
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates
      • Suffolk, Virginia, United States, 23435
        • Recruiting
        • Virginia Oncology Associates
      • Williamsburg, Virginia, United States, 23188
        • Recruiting
        • Virginia Oncology Associates
    • Washington
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Northwest Cancer Specialists, P.C.
    • Wisconsin
      • Hudson, Wisconsin, United States, 54016
        • Recruiting
        • Minnesota Oncology Hematology, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women ≥18 years of age who are confirmed not pregnant at screening.
  • Histologically or cytologically confirmed endometrial cancer that is recurrent or advanced; carcinosarcomas are eligible but pure sarcomas are excluded.
  • Newly diagnosed FIGO Stage III disease with measurable disease per RECIST v1.1, newly diagnosed FIGO Stage IV disease with or without measurable disease, or recurrent disease with or without measurable disease for which curative treatment with surgery and/or radiotherapy is unlikely.
  • For participants with recurrent disease, prior adjuvant systemic anti-cancer therapy is allowed if relapse occurred more than 6 months after the last dose.
  • Must provide tumor tissue for prospective central assessment of MMR and p53 status.
  • Proficient mismatch repair (pMMR) endometrial cancer as determined by central testing.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Life expectancy of at least 12 weeks.
  • Adequate organ function as defined in the protocol.

Exclusion Criteria:

  • Prior systemic therapy for first-line advanced or recurrent endometrial cancer.
  • Prior immunotherapy or anti-angiogenic therapy.
  • Deficient mismatch repair (dMMR) endometrial cancer by central testing.
  • Active or untreated central nervous system (CNS) metastases; participants with previously treated and clinically stable brain metastases may be eligible if not requiring steroids and without evidence of progression.
  • Clinically significant risk of bleeding or fistula, including a history of severe bleeding disorders.
  • History of another malignancy within 3 years, except for cancers with negligible risk of recurrence or death.
  • History of allogeneic organ or hematopoietic stem cell transplantation; active autoimmune disease requiring systemic treatment within the past 2 years; or history of immunodeficiency
  • Interstitial lung disease, pneumonitis, or clinically significant pulmonary disease
  • Uncontrolled or significant cardiovascular, metabolic, renal, hepatic, or vascular disease
  • Active or uncontrolled infection.
  • Recent major surgery or severe trauma within protocol-defined washout periods.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PF-08634404 plus Chemotherapy

PF-08634404 plus Chemotherapy, followed by PF-08634404 maintenance therapy
Biological: PF-08634404

Solution for IV infusion

Drug: Standard of Care Chemotherapy

Solution for IV infusion
Active Comparator: Pembrolizumab plus Chemotherapy

Pembrolizumab plus Chemotherapy, followed by Pembrolizumab maintenance therapy
Drug: Standard of Care Chemotherapy

Solution for IV infusion

Biological: Pembrolizumab

Solution for IV infusion

Other Names:
  • keytruda

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) using RECIST v1.1 as assessed by Blinded Independent Central Review (BICR)
Time Frame: Approximately 36 months

PFS by BICR is defined as the time from the date of randomization to the date of first documented disease progression per RECIST v1.1 as assessed by BICR, or death due to any cause, whichever occurs first.
Approximately 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Approximately 56 months

OS is defined as the time from the date of randomization to the date of death due to any cause.
Approximately 56 months
PFS using RECIST v1.1 as assessed by investigator
Time Frame: Approximately 36 months

PFS by investigator is defined as the time from the date of randomization to the date of first documented disease progression per RECIST v1.1 as assessed by investigator, or death due to any cause, whichever occurs first. PFS by investigator will be analyzed with the same methodology as for PFS by BICR.
Approximately 36 months
Objective Response Rate (ORR) as assessed by BICR and investigator
Time Frame: Approximately 56 months

Proportion of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1, assessed by BICR and by investigator
Approximately 56 months
Duration of Response (DoR) as assessed by BICR and investigator
Time Frame: Approximately 56 months

Time from first documented CR or PR to disease progression or death, per RECIST v1.1, assessed by BICR and by investigator
Approximately 56 months
Number of participants with treatment-emergent adverse events
Time Frame: Through end of the study and up to approximately 56 months

AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s)
Through end of the study and up to approximately 56 months
Number of participants with laboratory abnormalities
Time Frame: Through end of the study and up to approximately 56 months

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. For laboratory tests without CTCAE grade definitions, results will be categorized as normal, high, low, or not done and be listed.
Through end of the study and up to approximately 56 months
Serum concentrations of PF-08634404
Time Frame: Through end of the study and up to approximately 56 months

Pre-dose and post-dose serum concentrations of PF-08634404
Through end of the study and up to approximately 56 months
Incidence of ADA against PF-08634404
Time Frame: Through end of the study and up to approximately 56 months

Incidence of anti-drug antibodies (ADA) to PF-08634404
Through end of the study and up to approximately 56 months
Change from baseline in the global health status/quality of life (QoL) and physical functioning scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time Frame: Baseline, up to approximately 56 months

The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials. The core instrument is a 30-item questionnaire consisting of the following:

  • 5 Functional scales (physical, role, cognitive, emotional, social)
  • 3 Symptom scales (fatigue, pain, nausea, and vomiting, shortness of breath, loss of appetite, sleep disturbance, constipation, diarrhea) and financial impact of the disease
  • 2 Global items (global health status, overall HRQoL) All of the scales and single-item measures range in score from 0 to 100. High scale score represents a higher response level.
Baseline, up to approximately 56 months
Change from baseline in the back pain/pelvis pain, GI symptoms, and urological symptoms scales of the EORTC QLQ EN24
Time Frame: Baseline, up to approximately 56 months

The Endometrial Cancer Module (EORTC QLQ-EN24) is a disease-specific measure that is supplemental to the EORTC QLQ-C30 to capture patient's experiences with endometrial cancer-specific symptoms and impacts. The recall period is the past week. The 24-item questionnaire consists of the following:

  • Symptom scales/items (Lymphoedema, urological symptoms, gastrointestinal symptoms, poor body image, and sexual/vaginal problems, pain in back and pelvis, tingling/numbness, muscular pain, hair loss, and taste change)
  • Functional scales (sexual interest, sexual activity, and sexual enjoyment)

Higher scores for functional scales represent high level of functioning, while higher scores for symptoms scales represent higher levels of symptoms/problems.
Baseline, up to approximately 56 months
Time to definitive deterioration in the global health status/QoL and physical functioning scale of the EORTC QLQ-C30.
Time Frame: Approximately 56 months

The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30), is a validated 30-item self-administered core questionnaire designed to assess HRQoL, functioning, and symptoms in all cancer patients or survivors.

Time to deterioration is defined as time from baseline (defined as day 1 of cycle 1 before first application of maintenance therapy) to the date of the first clinically meaningful deterioration i.e. a decrease by ≥10 points for the functional scales and an increase by ≥ 10 points for the symptom scales or death in:

  • Physical functioning score
  • Role functioning score
Approximately 56 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C6461018
  • 2026-525584-40-00 (Registry Identifier: CTIS (EU))
  • GOG-3145 (Other Identifier: APGOT)
  • ENGOT-en37 (Other Identifier: APGOT)
  • APGOT-EN6 (Other Identifier: APGOT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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