Recruiting NCT07227415

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

Phase I / Phase II Interventional Carcinoma, Renal Cell Advanced Renal Cell Carcinoma Renal Cancer Renal Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: PF-08634404, Ipilimumab, Axitinib.
Who it may be relevant to: Registry conditions: Carcinoma, Renal Cell, Advanced Renal Cell Carcinoma, Renal Cancer, Renal Neoplasm. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, China, Germany, Japan +1
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

Drug PF-08634404
Concentrate for solution for infusion
Drug Ipilimumab
Solution for infusion
Drug Axitinib
Tablet

Primary outcome measures

Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator [Time frame: Up to approximately 3 years]
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Through 90 days after the last study intervention (Up to approximately 3 years)]
Number of participants with dose limiting toxicity (DLT) [Time frame: Though end of DLT evaluation period (Up to approximately 3 years)]

Secondary outcome measures (6)

Duration of Response (DOR) per RECIST v1.1 by investigator [Time frame: Up to approximately 3 years]
Progression Free Survival (PFS) per RECIST v1.1 by investigator [Time frame: Up to approximately 3 years]
Overall Survival (OS) [Time frame: Up to approximately 3 years]
Number of Participants With Clinical Laboratory Abnormalities [Time frame: Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (approximately 3 years)]
Pharmacokinetics (PK): Serum concentration of PF-08634404 [Time frame: Up to 37 days after the last dose of treatment]
Incidence of Anti-Drug Antibody (ADA) against PF-08634404 [Time frame: Up to 37 days after the last dose of treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Sequential
Masking: Open label
Primary purpose: Treatment