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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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • PF-08634404

    Drug

    Concentrate for solution for infusion

  • Ipilimumab

    Drug

    Solution for infusion

  • Axitinib

    Drug

    Tablet

  • Casdatifan

    Drug

    Tablet

Treatment groups

224 Participants
are divided into 4 treatment groups
Group A: Cohort AExperimental treatment 1 intervention
Group B: Cohort BExperimental treatment 2 interventions
Group C: Cohort CExperimental treatment 2 interventions
Group D: Cohort DExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator

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.

Time frame
Up to approximately 3 years
2

Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

Time frame
Through 90 days after the last study intervention (Up to approximately 3 years)
3

Number of participants with dose limiting toxicity (DLT)

The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).

Time frame
Though end of DLT evaluation period (Up to approximately 3 years)

Secondary outcomes

1

Duration of Response (DOR) per RECIST v1.1 by investigator

DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.

Time frame
Up to approximately 3 years
2

Progression Free Survival (PFS) per RECIST v1.1 by investigator

Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.

Time frame
Up to approximately 3 years
3

Overall Survival (OS)

Overall survival defined as the time from the date of randomization to the date of death due to any cause.

Time frame
Up to approximately 3 years
4

Number of Participants With Clinical Laboratory Abnormalities

laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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