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 (NCT07227415) — USA Trial Details

Condition(s) studied

Carcinoma, Renal CellAdvanced Renal Cell CarcinomaRenal CancerRenal NeoplasmClear Cell Renal Cell CarcinomaMetastatic Renal Cell CarcinomaClear-cell Metastatic Renal Cell CarcinomaCarcinoma, Renal Cell MetastasisAdvanced or Metastatic Renal Cell CarcinomaCarcinoma, Renal Cell, AdvancedMetastatic Renal Cell CancerMetastatic Renal Cell Carcinoma ( mRCC)Metastatic/Advanced Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

PF-08634404IpilimumabAxitinibCasdatifan

PF-08634404: Concentrate for solution for infusion

Ipilimumab: Solution for infusion

Axitinib: Tablet

Casdatifan: Tablet

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Inclusion Criteria: * 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 Exclusion Criteria: 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

Primary outcome measure(s)

Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator — Up to approximately 3 years
ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1 as assessed by investigator.
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — Through 90 days after the last study intervention (Up to approximately 3 years)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Number of participants with dose limiting toxicity (DLT) — Though end of DLT evaluation period (Up to approximately 3 years)
The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).

Trial sites (162)

Facility	City	Region	Status
Mayo Clinic Building- Phoenix	Phoenix	Arizona	Recruiting
Mayo Clinic Arizona	Scottsdale	Arizona	Recruiting
Highlands Oncology Group	Fayetteville	Arkansas	Recruiting
Highlands Oncology Group	Rogers	Arkansas	Recruiting
Highlands Oncology Group, PA	Springdale	Arkansas	Recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)	Duarte	California	Recruiting
City of Hope Investigational Drug Services (IDS)	Duarte	California	Recruiting
UC San Diego Medical Center - Encinitas	Encinitas	California	Recruiting
City of Hope at Irvine Lennar	Irvine	California	Recruiting
City of Hope Investigational Drug Services (IDS)	Irvine	California	Recruiting
UC San Diego / Moores Cancer Center	La Jolla	California	Recruiting
UC San Diego Koman Family Outpatient Pavilion	La Jolla	California	Recruiting
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)	La Jolla	California	Recruiting
UC San Diego Sulpizio Cardiovascular Center	La Jolla	California	Recruiting
City of Hope	Long Beach	California	Recruiting
UC San Diego Medical Center - Bankers Hill	San Diego	California	Recruiting
UC San Diego McGrath Outpatient Pavilion - Hillcrest	San Diego	California	Recruiting
UC San Diego Medical Center - Hillcrest	San Diego	California	Recruiting
UC San Diego Medical Center - Rancho Bernardo	San Diego	California	Recruiting
City of Hope UPLAND	Upland	California	Recruiting
UC San Diego Medical Center - Vista	Vista	California	Recruiting
Rocky Mountain Cancer Centers,LLP	Aurora	Colorado	Recruiting
Clinical and Translational Research Center(CTRC)	Aurora	Colorado	Not Yet Recruiting
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)	Aurora	Colorado	Not Yet Recruiting
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)	Aurora	Colorado	Not Yet Recruiting
University of Colorado Hospital-Anschutz Cancer Pavilion (ACP)	Aurora	Colorado	Not Yet Recruiting
UCHealth Cherry Creek Medical Center	Denver	Colorado	Not Yet Recruiting
Rocky Mountain Cancer Centers,LLP	Denver	Colorado	Recruiting
Highlands Ranch Hospital	Highlands Ranch	Colorado	Not Yet Recruiting
Rocky Mountain Cancer Centers, LLP	Lakewood	Colorado	Recruiting
Rocky Mountain Cancer Centers,LLP	Lone Tree	Colorado	Recruiting
UC Health Lone Tree Medical Center	Lone Tree	Colorado	Not Yet Recruiting
Mayo Clinic Pharmacy	Jacksonville	Florida	Recruiting
Orlando Health Ambulatory Care Center	Orlando	Florida	Recruiting
Orlando Health Cancer Institute	Orlando	Florida	Recruiting
Orlando Health Orlando Regional Medical Center	Orlando	Florida	Recruiting
Tennessee Oncology, PLLC- Ringgold	Ringgold	Georgia	Recruiting
Memorial Hospital	Shiloh	Illinois	Recruiting
Siteman Cancer Center - Shiloh	Shiloh	Illinois	Recruiting
City Of Hope - Chicago	Zion	Illinois	Recruiting

+ 122 more sites — see the full list on the official registry below.

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