Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer (NCT07421700)
AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER
🩺 Plain-English Summary (8th-Grade Level)
This study is being done to learn more about a new medicine called PF-08634404. It is for adults with a type of bladder cancer called locally advanced or metastatic urothelial cancer (LA/mUC), meaning the cancer has spread to nearby tissues or other parts of the body. The purpose of the study is to see if PF-08634404 is safe, how well it works, how it moves through the body, and how it affects the cancer. The study will also look at how the medicine may change certain markers in the body that are linked to cancer. To join the study, participants must: * Be adults (18 years or older) and * Have locally advanced or metastatic urothelial cancer, The study has two groups: * Cohort A: People who have already received treatment for their cancer will get the study medicine ( PF-08634404) alone. * Cohort B: People who have not had treatment before will get the study medicine along with another cancer medicine called enfortumab vedotin. Everyone in the study will get the study medicine through a vein (IV infusion) with or without enfortumab vedotin. Treatment will continue as long as it helps and side effects are manageable. Before starting, participants will go through a screening period to check if they are eligible. During the study, they will have regular visits for treatment, health checks, and tests to see how the cancer is responding. Scans will be done regularly to monitor the cancer. If the cancer gets worse but the treatment is still helping and side effects are manageable, participants may be allowed to continue treatment with their doctor's and the sponsor's agreement.
Who can join: Review the eligibility criteria below.
Location: Highlands Oncology Group, PA — Fayetteville, Arkansas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (153 Sites)
Showing the first 25 of 153 sites.
- Highlands Oncology Group, PA — Fayetteville, Arkansas
- Highlands Oncology Group, PA — Rogers, Arkansas
- Highlands Oncology Group, PA — Springdale, Arkansas
- UCLA Hematology/Oncology - Alhambra — Alhambra, California
- UCLA Hematology/Oncology - Atascadero — Atascadero, California
- UCLA Hematology/Oncology - Beverly Hills — Beverly Hills, California
- UCLA Hematology/Oncology - Burbank — Burbank, California
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California
- City of Hope Investigational Drug Services (IDS) — Duarte, California
- UC San Diego Medical Center - Encinitas — Encinitas, California
- UCLA Hematology/Oncology - Encino — Encino, California
- UCLA Hematology/Oncology - Irvine — Irvine, California
- City of Hope at Irvine Lennar — Irvine, California
- City of Hope Investigational Drug Service (IDS) — Irvine, California
- UC San Diego Koman Family Outpatient Pavilion — La Jolla, California
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) — La Jolla, California
- UC San Diego Moores Cancer Center — La Jolla, California
- UC San Diego Shiley Eye Institute — La Jolla, California
- UC San Diego Sulpizio Cardiovascular Center — La Jolla, California
- Viterbi Family Department of Ophthalmology — La Jolla, California
- UCLA Hematology Oncology- Laguna Hills — Laguna Hills, California
- City of Hope-Long Beach (ELM) — Long Beach, California
- (IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center — Los Angeles, California
- UCLA Hematology/Oncology — Los Angeles, California
- UCLA Hematology/Oncology - Marina del Rey — Marina del Rey, California
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Urothelial Cancer
- Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer — Chandler, Arizona
- A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations — Anchorage, Alaska
- A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer — Cleveland, Ohio
- A Genotype-Phenotype Urothelial Cancer Registry — Basking Ridge, New Jersey
- Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies — Bethesda, Maryland
- Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer — Los Angeles, California
Explore by condition: All Urothelial Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.