Sasanlimab for Bladder Cancer

(CREST Trial)

Not currently recruiting at 268 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: Chemotherapy, Immunotherapy, Immunostimulatory agents

Disqualifiers: Muscle-invasive cancer, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Induction period: 6 weeks; Maintenance period: up to 60 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests sasanlimab, a new medicine for individuals with early-stage, non-muscle invasive bladder cancer that remains confined to the bladder. Researchers aim to assess the safety and effectiveness of sasanlimab, particularly for those with high-risk cancer or those previously treated with BCG, a common bladder cancer treatment. The trial includes different groups to compare sasanlimab alone and in combination with BCG. It suits individuals whose bladder cancer was surgically removed and who have refused or are ineligible for major bladder removal surgery. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does exclude participants who have had certain types of chemotherapy or immunotherapy recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that sasanlimab, when combined with BCG (a common bladder cancer treatment), is usually well-tolerated by patients. Studies have found that this combination benefits people with non-muscle invasive bladder cancer. These studies have reported no major safety issues. Common side effects include fatigue and mild reactions at the injection site, which are typically manageable. Discuss any concerns with the study team, as they can provide detailed information specific to your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Sasanlimab for bladder cancer because it offers a new approach by targeting the PD-1 pathway, which could enhance the immune system's ability to attack cancer cells. While the standard treatment often involves Bacillus Calmette Guerin (BCG) therapy, combining Sasanlimab with BCG could potentially boost the effectiveness of this traditional method. Additionally, Sasanlimab is being explored for its ability to treat BCG-unresponsive bladder cancer, providing a promising option for patients who do not respond to existing treatments. This novel mechanism of action and the possibility of treating resistant cases are key reasons for the excitement surrounding Sasanlimab.

What evidence suggests that this trial's treatments could be effective for bladder cancer?

Research has shown that sasanlimab, when combined with BCG (a type of vaccine), can significantly improve outcomes for people with non-muscle invasive bladder cancer. In this trial, participants may receive sasanlimab with BCG either as induction only or as both induction and maintenance therapy. One important study found that this combination reduced the risk of cancer-related issues, such as recurrence, by 32%. Additionally, patients reported that their quality of life remained unchanged with this treatment compared to using BCG alone. These findings suggest that sasanlimab may help lower the chance of cancer returning while maintaining patients' everyday life. ^{1 2 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for people with early-stage bladder cancer that hasn't spread, was surgically removed, and is high risk. Participants must have had BCG treatment but can't join if they've had prior radiation to the bladder, muscle-invasive or advanced cancer, certain other treatments like immunotherapy, or participated in part A of this study.

Inclusion Criteria

My bladder cancer is high-risk, not invasive, and didn't respond to BCG therapy.

I had all my bladder tumors surgically removed recently.

My bladder cancer is mainly transitional cell type and considered high risk.

Exclusion Criteria

My cancer has spread beyond the bladder lining or is in advanced stages.

I have previously received immunotherapy targeting PD-1, PD-L1, PD-L2, or CTLA-4.

I have previously been treated with immune-stimulating drugs like IL-2 or interferon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-06801591 in combination with Bacillus Calmette-Guerin (BCG) or BCG alone, depending on the assigned group

Induction period: 6 weeks; Maintenance period: up to 60 months

Regular visits at the study clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Sasanlimab

Trial Overview The study tests sasanlimab's safety and effects on non-muscle invasive bladder cancer. It has two parts: Part A (closed) compared sasanlimab plus BCG against BCG alone; Part B assigns new participants based on tumor type to receive sasanlimab at the clinic.

How Is the Trial Designed?

Group I: PF-06801591 + BCG induction only Experimental Treatment 2 Interventions

PF-06801591 in combination with Bacillus Calmette Guerin (induction only).

Group II: PF-06801591 + BCG induction and maintenance Experimental Treatment 2 Interventions

PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).

Group III: BCG Unresponsive NMIBC Experimental Treatment 1 Intervention

PF-06801591

Group IV: BCG Unresponsive CIS Experimental Treatment 1 Intervention

PF-06801591

Group V: BCG induction and maintenance Active Control 1 Intervention

Bacillus Calmette Guerin (induction and maintenance).

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Neoadjuvant chemotherapy has been shown to improve overall survival in patients with locally advanced muscle-invasive bladder cancer, but its use in clinical practice remains low due to ongoing controversies regarding adjuvant chemotherapy.

Recent advancements include the approval of atezolizumab, a checkpoint inhibitor, for metastatic bladder cancer, alongside other promising therapies targeting mutational signatures, such as VEGF and HER2-directed agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic therapy in muscle-invasive and metastatic bladder cancer: current trends and future promises. Aragon-Ching, JB., Trump, DL.[2017]

MPDL3280A, an anti-PD-L1 antibody, shows significant activity in treating metastatic urothelial bladder cancer (UBC), with rapid responses often observed within 6 weeks, particularly in patients with PD-L1-positive tumors.

The treatment has a favorable safety profile, lacking renal toxicity, making it potentially more tolerable for older patients with UBC who may have renal impairment compared to traditional chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Powles, T., Eder, JP., Fine, GD., et al.[2022]

Urothelial carcinoma, the most common urological cancer, is primarily treated with Bacillus Calmette-Guerin (BCG) immunotherapy for superficial cases and cisplatin-based chemotherapy for metastatic disease, with vinflunine as the standard second-line option in Europe.

Novel PD-1/PD-L1 inhibitors like atezolizumab, nivolumab, and pembrolizumab have shown promise in treating bladder cancer, particularly for patients who cannot tolerate cisplatin, and are generally well tolerated with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Immunotherapy for Bladder Cancer]. Büchler, T.[2019]

The introduction of PD-L1/PD-1 inhibition therapy has significantly changed treatment strategies for advanced urothelial bladder cancer, showing efficacy in both first-line and second-line treatment settings.

Despite the promise of PD-L1/PD-1 therapies, the proportion of patients who actually benefit from these treatments remains low, highlighting the need for better biomarker-driven approaches to improve patient selection and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed death ligand-1/programmed death-1 inhibition therapy and programmed death ligand-1 expression in urothelial bladder carcinoma. Yu, WB., Rao, JY.[2020]

Citations

1. nature.com nature.com/articles/s41591-025-03738-z

Sasanlimab plus BCG in BCG-naive, high-risk non-muscle ... Impact of baseline PD-L1 status in BCG naive nonmuscle invasive bladder cancer on outcomes and changes after BCG exposure. Urol. Oncol ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04165317

NCT04165317 | A Study of Sasanlimab in People With Non ... The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer.

3. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizers-sasanlimab-combination-significantly-improves-event

Pfizer's Sasanlimab Combination Significantly Improves ... Pivotal Phase 3 CREST trial results show a 32% reduction in the risk of disease-related events, including high-grade disease recurrence or ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4610

Sasanlimab in combination with bacillus Calmette-Guérin ... PROs from CREST showed QOL was maintained when combining sasanlimab with BCG vs BCG (both IND + MNT). These results can help inform the benefit-risk assessment ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38189180/

phase III study of sasanlimab and Bacillus Calmette-Guérin ... CREST is a phase III study evaluating the efficacy and safety of the subcutaneous PD-1 inhibitor sasanlimab in combination with BCG for patients with BCG-naive ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40450141/

Sasanlimab plus BCG in BCG-naive, high-risk non-muscle ... Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial · Abstract · Publication types.

7. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizers-sasanlimab-combination-bcg-improves-event-free

Pfizer's Sasanlimab in Combination with BCG Improves ... “Patients with BCG-naïve high-risk non-muscle invasive bladder cancer have high rates of recurrence and progression,” said Neal Shore, M.D., ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4517

Sasanlimab in combination with bacillus Calmette-Guérin ... Sasanlimab in combination with BCG (IND and MNT) improved EFS outcomes in the overall population and in the subgroups of pts with BCG-naive, high-risk NMIBC.