Health Trials

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

ConditionsCarcinoma, 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
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • PF-08634404
  • Ipilimumab
  • Axitinib

Treatment groups

224 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Pfizer

Lead sponsor

Source ClinicalTrials.gov