ClinicalTrials.gg
RecruitingNCT07227415Updated Oct 8, 2026

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 Phase 1/2 interventional study of PF-08634404 and Ipilimumab in Carcinoma, Renal Cell, Advanced Renal Cell Carcinoma and Renal Cancer, sponsored by Pfizer. Recruiting at 183 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Primary conditionClear-cell metastatic renal cell carcinomaRegistry: Carcinoma, Renal CellReclassifiedWhy we changed it
Registry
Carcinoma, Renal Cell — the first condition term the registry derived for this study.
ClinicalTrials.gg
Clear-cell metastatic renal cell carcinoma
Why
  1. The study's listed conditions name Clear-cell metastatic renal cell carcinoma, a narrower term within Carcinoma, Renal Cell.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Pfizer · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Updated Oct 8, 2026Site recruiting status changed22 sites added+1 moreGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1/2
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 38 studies in Clear-cell metastatic renal cell carcinoma with a site in United States — 17 open to participants now, 22 under way, 3 of them phase 3. Clear-cell metastatic renal cell carcinoma · United States.

Planned enrollment
5th of 37
224 · median 34
Started
2026
with 8 others
Phase 1/2
5 of 38
2 open now
Primary completion
2027-11
later than 10 of 21 live
Registered
33rd of 38
by date

Among the 38 studies in Clear-cell metastatic renal cell carcinoma with a site in United States, this one is the 5th largest by planned enrollment of the 37 interventional ones that give a count, is one of 9 that started in 2026, is one of 5 in phase 1/2, reaches primary completion later than 10 of the 21 other live ones, and was the 33rd registered.

Clear-cell metastatic renal cell carcinoma

70 studies on the registry are indexed under Clear-cell metastatic renal cell carcinoma; 31 are open to participants now.

Browse Clear-cell metastatic renal cell carcinoma studies →

Open to participants now

17 of the 38 studies in Clear-cell metastatic renal cell carcinoma with a site in United States are open now. Recruiting first, the newest first:

11 more — sign in →

All 17 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 25 Clear-cell metastatic renal cell carcinoma studies recruiting now, 22 (88%) set no upper age limit and 1 (4%) stops at 75 or younger; none take children under 18; none take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 38 studies in Clear-cell metastatic renal cell carcinoma with a site in United States, or all of them as a file.
02

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.

03

Conditions studied

  • 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

Keywords

  • Renal cell carcinoma
  • renal cancer
  • renal neoplasm
04

In context

Clear-cell metastatic renal cell carcinoma Reclassified

70 studies on the registry are indexed under Clear-cell metastatic renal cell carcinoma; 31 are open to participants now.

This study's planned enrollment of 224 is above the median of 39 across 63 interventional studies indexed under Clear-cell metastatic renal cell carcinoma.

Browse Clear-cell metastatic renal cell carcinoma studies →

Lead sponsor

Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.

Compared within Clear-cell metastatic renal cell carcinoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Carcinoma, Renal Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years of age or older at screening
  • Locally advanced (not amenable to curative surgery or radiation therapy) or 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)
  • (ECOG) performance status 0 or 1.
  • All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories

Exclusion criteria

Exclusion Criteria:

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

  • Known active brain lesions including , brainstem, meningeal or spinal cord or compression.
  • risk of haemorrhage or fistula
  • History of another within 3 years
  • History of allogeneic organ transplantation and hematopoietic stem cell transplantation.
  • active 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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

06

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
224 participants (estimated)

Study arms

  • Experimental
    Cohort A

    Participants will receive PF-08634404 IV.

    Drug: PF-08634404

  • Experimental
    Cohort B

    Participants will receive PF-08634404 in combination with ipilimumab.

    Drug: PF-08634404 · Drug: Ipilimumab

  • Experimental
    Cohort C

    Participants will receive PF-08634404 IV in combination with axitinib.

    Drug: PF-08634404 · Drug: Axitinib

  • Experimental
    Cohort D

    Participants will receive PF-08634404 in combination with Casdatifan.

    Drug: PF-08634404 · Drug: Casdatifan

Interventions

07

What researchers measure

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)

  5. Pharmacokinetics (PK): Serum concentration of PF-08634404

    Pre-dose and post dose concentrations of PF-08634404

    Time frame: Up to 37 days after the last dose of treatment

  6. Incidence of Anti-Drug Antibody (ADA) against PF-08634404

    To evaluate the immunogenicity of PF-08634404

    Time frame: Up to 37 days after the last dose of treatment

08

Study locations

157 of 183 sites recruiting

Showing the first 100 of 183 sites across 6 countries. Choose a country and city above to see the rest.

09

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2026 (actual). Primary completion is estimated for Nov 2027, 20 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2025
First posted
Nov 12, 2025
StartActual
Feb 10, 2026
Primary completionEst.
Nov 2, 2027
CompletionEst.
Nov 1, 2028
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
22 sites added, 1 site removed. 9 sites changed recruiting status (9 now recruiting)
Show 9 sites
  • Clinical and Translational Research Center(CTRC) · Aurora, United StatesNot yet recruiting→Recruiting
  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) · Aurora, United StatesNot yet recruiting→Recruiting
  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) · Aurora, United StatesNot yet recruiting→Recruiting
  • University of Colorado Hospital-Anschutz Cancer Pavilion (ACP) · Aurora, United StatesNot yet recruiting→Recruiting
  • UCHealth Cherry Creek Medical Center · Denver, United StatesNot yet recruiting→Recruiting
  • Highlands Ranch Hospital · Highlands Ranch, United StatesNot yet recruiting→Recruiting
  • UC Health Lone Tree Medical Center · Lone Tree, United StatesNot yet recruiting→Recruiting
  • Henry-Joyce Cancer Clinic · Nashville, United StatesNot yet recruiting→Recruiting
  • Chongqing University Cancer Hospital · Chongqing, ChinaNot yet recruiting→Recruiting
Show 22 added (21 United States, 1 Germany)
  • UCLA Hematology/Oncology - Alhambra · Alhambra, United States
  • UCLA Hematology/Oncology - Atascadero · Atascadero, United States
  • UCLA Hematology/Oncology - Burbank · Burbank, United States
  • UCLA Hematology/Oncology- Encino · Encino, United States
  • UCLA Hematology/Oncology- Irvine · Irvine, United States
  • UCLA Hematology/Oncology - Laguna Hills · Laguna Hills, United States
  • Investigational Drug Services, Bowyer Pharmacy · Los Angeles, United States
  • Ronald Reagan UCLA Medical Center, Drug Information Center · Los Angeles, United States
  • UCLA Hematology/Oncology · Los Angeles, United States
  • UCLA Hematology/Oncology - Marina del Rey · Marina del Rey, United States
  • UCLA Hematology/Oncology - Pasadena · Pasadena, United States
  • UCLA Hematology/Oncology - Porter Ranch · Porter Ranch, United States
  • UCLA Hematology/Oncology - San Luis Obispo · San Luis Obispo, United States
  • UCLA Hematology/Oncology- Santa Barbara · Santa Barbara, United States
  • UCLA Hematology/Oncology - Santa Monica · Santa Monica, United States
  • UCLA Hematology/Oncology- Torrance · Torrance, United States
  • UCLA Hematology/Oncology - Santa Clarita · Valencia, United States
  • UCLA Hematology/Oncology- Ventura · Ventura, United States
  • UCLA Hematology/Oncology- Westlake · Westlake Village, United States
  • Orlando Health Cancer Institute · Lake Mary, United States
  • Dana-Farber Cancer Institute · Boston, United States
  • Heidelberg University Hospital · Heidelberg, Germany
Show 1 removed
  • Dana Farber/Mass General Brigham Cancer Care, Inc · Boston, United States
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    22 sites added, 1 site removed. 9 sites changed recruiting status (9 now recruiting)
    Show 9 sites
    • Clinical and Translational Research Center(CTRC) · Aurora, United StatesNot yet recruiting→Recruiting
    • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) · Aurora, United StatesNot yet recruiting→Recruiting
    • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) · Aurora, United StatesNot yet recruiting→Recruiting
    • University of Colorado Hospital-Anschutz Cancer Pavilion (ACP) · Aurora, United StatesNot yet recruiting→Recruiting
    • UCHealth Cherry Creek Medical Center · Denver, United StatesNot yet recruiting→Recruiting
    • Highlands Ranch Hospital · Highlands Ranch, United StatesNot yet recruiting→Recruiting
    • UC Health Lone Tree Medical Center · Lone Tree, United StatesNot yet recruiting→Recruiting
    • Henry-Joyce Cancer Clinic · Nashville, United StatesNot yet recruiting→Recruiting
    • Chongqing University Cancer Hospital · Chongqing, ChinaNot yet recruiting→Recruiting
    Show 22 added (21 United States, 1 Germany)
    • UCLA Hematology/Oncology - Alhambra · Alhambra, United States
    • UCLA Hematology/Oncology - Atascadero · Atascadero, United States
    • UCLA Hematology/Oncology - Burbank · Burbank, United States
    • UCLA Hematology/Oncology- Encino · Encino, United States
    • UCLA Hematology/Oncology- Irvine · Irvine, United States
    • UCLA Hematology/Oncology - Laguna Hills · Laguna Hills, United States
    • Investigational Drug Services, Bowyer Pharmacy · Los Angeles, United States
    • Ronald Reagan UCLA Medical Center, Drug Information Center · Los Angeles, United States
    • UCLA Hematology/Oncology · Los Angeles, United States
    • UCLA Hematology/Oncology - Marina del Rey · Marina del Rey, United States
    • UCLA Hematology/Oncology - Pasadena · Pasadena, United States
    • UCLA Hematology/Oncology - Porter Ranch · Porter Ranch, United States
    • UCLA Hematology/Oncology - San Luis Obispo · San Luis Obispo, United States
    • UCLA Hematology/Oncology- Santa Barbara · Santa Barbara, United States
    • UCLA Hematology/Oncology - Santa Monica · Santa Monica, United States
    • UCLA Hematology/Oncology- Torrance · Torrance, United States
    • UCLA Hematology/Oncology - Santa Clarita · Valencia, United States
    • UCLA Hematology/Oncology- Ventura · Ventura, United States
    • UCLA Hematology/Oncology- Westlake · Westlake Village, United States
    • Orlando Health Cancer Institute · Lake Mary, United States
    • Dana-Farber Cancer Institute · Boston, United States
    • Heidelberg University Hospital · Heidelberg, Germany
    Show 1 removed
    • Dana Farber/Mass General Brigham Cancer Care, Inc · Boston, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT07227415
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Nov 12, 2025
Start date
Feb 10, 2026
Primary completion
Nov 2, 2027 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Oct 8, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Anti-PD-1/Anti-VEGF Bispecific Antibody PF-08634404

Start the discussion