Not currently recruiting at UCLA

Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

a study on Renal Cell Carcinoma Kidney Cancer Carcinoma, Renal Cell Metastasis Carcinoma, Renal Cell, Advanced Kidney Neoplasm Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Alhambra, California and other locations
Dates
study started
study ends around

Description

Summary

This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them.

To join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer.

Participants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.

Official Title

AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Keywords

Carcinoma, Renal Cell, Advanced Renal Cell Carcinoma, Renal Cancer, Renal Neoplasm, Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Clear-cell Metastatic Renal Cell Carcinoma, Carcinoma, Renal Cell Metastasis, Advanced or Metastatic Renal Cell Carcinoma, Carcinoma, Renal Cell, Advanced, Metastatic Renal Cell Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Metastatic/Advanced Renal Cell Carcinoma, Renal cell carcinoma, Kidney Neoplasms, Carcinoma, Neoplasm Metastasis, Ipilimumab, Axitinib, Casdatifan

Eligibility

You can join if…

Open to people ages 18 years and up

  • 18 years of age or older at screening
  • Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology
  • At least one measurable (as defined by the investigator) and untreated lesion
  • Adequate hematologic, hepatic, cardiac and renal function
  • No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received >12 months prior)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories

You CAN'T join if...

Participants may be excluded if they meet any of the following:

  • Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.
  • Clinically significant risk of haemorrhage or fistula
  • History of another malignancy within 3 years
  • History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • active autoimmune diseases requiring systemic treatment within the past 2 years
  • uncontrolled cardiac and other comorbidities within 6 months prior to the first dose
  • Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study
  • History of severe bleeding tendency or coagulation dysfunction
  • History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose
  • Acute, chronic or symptomatic infections
  • Participants with history of immunodeficiency

Locations

  • UCLA Hematology/Oncology - Alhambra not yet accepting patients
    Alhambra California 91801 United States
  • UCLA Hematology/Oncology - Burbank not yet accepting patients
    Burbank California 91505 United States
  • UCLA Hematology/Oncology- Encino not yet accepting patients
    Encino California 91436 United States
  • UCLA Hematology/Oncology- Irvine not yet accepting patients
    Irvine California 92604 United States
  • UCLA Hematology/Oncology - Laguna Hills not yet accepting patients
    Laguna Hills California 92653 United States
  • Investigational Drug Services, Bowyer Pharmacy not yet accepting patients
    Los Angeles California 90095 United States
  • Ronald Reagan UCLA Medical Center, Drug Information Center not yet accepting patients
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology not yet accepting patients
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology - Marina del Rey not yet accepting patients
    Marina del Rey California 90292 United States
  • UCLA Hematology/Oncology - Pasadena not yet accepting patients
    Pasadena California 91105 United States
  • UCLA Hematology/Oncology - Porter Ranch not yet accepting patients
    Porter Ranch California 91326 United States
  • UCLA Hematology/Oncology - Santa Monica not yet accepting patients
    Santa Monica California 90404 United States
  • UCLA Hematology/Oncology- Torrance not yet accepting patients
    Torrance California 90505 United States
  • UCLA Hematology/Oncology - Santa Clarita not yet accepting patients
    Valencia California 91355 United States
  • UCLA Hematology/Oncology- Ventura not yet accepting patients
    Ventura California 93003 United States
  • UCLA Hematology/Oncology- Westlake not yet accepting patients
    Westlake Village California 91361 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT07227415
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 224 study participants
Last Updated