Pembrolizumab Combination Therapies for Prostate Cancer

Recruiting at 50 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Merck Sharp & Dohme Corp.

Must be taking: Androgen deprivation therapy

Must not be taking: Immunosuppressive therapy, CYP3A4 inhibitors

Disqualifiers: Autoimmune disease, Pneumonitis, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different drug combinations to treat a specific type of prostate cancer that has spread and resists typical hormone treatments. Researchers aim to determine the safety and effectiveness of these combinations for individuals with metastatic castration-resistant prostate cancer (mCRPC). The study includes different groups, each receiving a unique mix of medicines, such as pembrolizumab (an immunotherapy drug), to identify the most effective treatment. Men whose prostate cancer has continued to grow despite treatment and who have experienced recent cancer progression might be suitable candidates for this trial.

As a Phase 1/Phase 2 trial, the study focuses on understanding how the treatment works in people and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like strong CYP3A4 inhibitors or inducers are restricted for some cohorts, and prior treatments with specific drugs may affect eligibility. It's best to discuss your current medications with the trial team to understand any potential conflicts.

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

Research shows that pembrolizumab, when combined with other treatments, exhibits varying safety levels depending on the combination.

For the pembrolizumab and olaparib combination, studies found that side effects align with those expected when each drug is used alone. Doctors typically observe the same side effects as when these drugs are used separately.

The combination of pembrolizumab and vibostolimab did not perform as well as anticipated in fighting cancer, but safety remained acceptable, with no unexpected or severe side effects.

When combined with abiraterone and prednisone, research indicates pembrolizumab is generally safe, suggesting patients can usually tolerate this treatment without severe side effects.

For pembrolizumab paired with lenvatinib, side effects are described as manageable, meaning they are usually not severe and can be managed by doctors.

Pembrolizumab and enzalutamide together showed additional side effects but were generally manageable, allowing patients to continue treatment.

Belzutifan, approved for other conditions, has a generally manageable safety profile, with side effects typically not serious enough to halt treatment.

Finally, the combination of pembrolizumab with docetaxel and prednisone, as well as with carboplatin and etoposide, has shown manageable safety in patients, suggesting these combinations are safe enough for clinical use, with controllable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they combine pembrolizumab, an immune checkpoint inhibitor, with other drugs to potentially amplify the body's immune response against cancer cells. Unlike traditional hormone therapies and chemotherapy, these combinations, such as pembrolizumab with olaparib or vibostolimab, target specific aspects of cancer cell survival and immune evasion, offering a more tailored and potentially effective approach. Additionally, the inclusion of novel agents like belzutifan, which impacts cancer cell metabolism, adds another layer of innovation that could improve outcomes for patients with advanced prostate cancer. These treatments aim to provide new hope for those who haven't responded well to existing therapies.

What evidence suggests that this trial's treatments could be effective for metastatic castration resistant prostate cancer?

Research has shown that pembrolizumab, when combined with other drugs, has varying success in treating advanced prostate cancer unresponsive to hormone therapy. In this trial, one arm will receive pembrolizumab with olaparib, which has demonstrated some tumor-fighting ability, though it did not significantly extend survival in patients with extensive prior treatment. Another arm will test pembrolizumab with abiraterone and prednisone, which showed promise in fighting tumors in patients without prior chemotherapy. However, adding pembrolizumab to enzalutamide and docetaxel, as tested in another arm, did not outperform standard treatments.

In separate arms, pembrolizumab with lenvatinib is under study. While it showed limited tumor-fighting ability, early research suggests it might help by affecting the tumor's blood supply. The combination of pembrolizumab and vibostolimab, tested in another arm, was not very effective in patients previously treated with docetaxel. Lastly, belzutifan, whether used alone or with pembrolizumab, is being evaluated for its potential to control cancer spread, but further research is needed to confirm its effectiveness. ^{5 6 7 8 9}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

Men with advanced prostate cancer that's resistant to hormone therapy and has spread, who are still undergoing androgen deprivation (testosterone <50 ng/dL). They must be relatively healthy (ECOG 0-2), able to provide a recent tumor sample, and have had cancer progression within the last 6 months. Participants should agree to contraception if applicable. Those with certain prior treatments or medical conditions like HIV, hepatitis B/C, brain metastases, or intense bone scans aren't eligible.

Inclusion Criteria

My prostate cancer biopsy shows specific cell types and has been confirmed by a central review.

I can provide a recent biopsy of my cancer that hasn't been radiated.

My prostate cancer has worsened in the last 6 months, shown by tests or scans.

Exclusion Criteria

Has known active Hepatitis B or Hepatitis C

I have had lung inflammation that needed steroids or have it now.

I have not received a live vaccine in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab combination therapies in various cohorts, with treatment continuing for a maximum of 35 cycles (up to 2 years) or until progression.

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Second Course Treatment (optional)

Participants who discontinue pembrolizumab after 35 infusions for reasons other than disease progression or intolerability may receive a second course of treatment with up to 17 additional infusions.

Approximately 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Abiraterone acetate
• Belzutifan
• Carboplatin
• Enzalutamide
• Etoposide
• Lenvatinib
• Olaparib
• Pembrolizumab
• Prednisone

Trial Overview The trial is testing how safe and effective pembrolizumab is when combined with other drugs in different groups of patients with metastatic castration-resistant prostate cancer. There are ten cohorts each receiving various combinations including pembrolizumab plus olaparib, docetaxel/prednisone, enzalutamide, abiraterone/prednisone among others.

How Is the Trial Designed?

Group I: Pembrolizumab/Vibostolimab coformulation:t-NE Experimental Treatment 1 Intervention

Participants with t-NE mCRPC in Cohort H will receive a coformulation fixed dose combination of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684) Q3W IV from Day 1 of Cycle 1. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.

Group II: Pembrolizumab/Vibostolimab coformulation Experimental Treatment 1 Intervention

Participants with AC mCRPC in Cohort G will receive a coformulation fixed dose combination of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684) Q3W IV from Day 1 of Cycle 1. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.

Group III: Pembrolizumab+Olaparib Experimental Treatment 3 Interventions

Participants with adenocarcinoma (AC) mCRPC in Cohort A will receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week dosing cycle (Q3W) and olaparib 400 mg capsules or 300 mg tablets by mouth (PO) twice a day (BID) continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue until progression or a maximum of 35 treatment cycles (up to 2 years). Treatment with olaparib will continue until progression. Participants who must discontinue 1 of the 2 drugs in the combination due to adverse events may continue the study with the other combination drug.

Group IV: Pembrolizumab+Lenvatinib:t-NE Experimental Treatment 2 Interventions

Participants with neuroendocrine (t-NE) mCRPC in Cohort F will receive pembrolizumab 200 mg IV on Day 1 Q3W, and lenvatinib 20 mg PO QD continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.

Group V: Pembrolizumab+Lenvatinib: AC Experimental Treatment 2 Interventions

Participants with AC mCRPC in Cohort E will receive pembrolizumab 200 mg IV on Day 1 Q3W, and lenvatinib 20 mg PO QD continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.

Group VI: Pembrolizumab+Enzalutamide Experimental Treatment 2 Interventions

Participants with AC mCRPC in Cohort C will receive pembrolizumab 200 mg IV on Day 1 Q3W and enzalutamide 160 mg PO every day (QD) continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue until progression or a maximum of 35 treatment cycles (up to 2 years). Treatment with enzalutamide will continue until progression. Participants who must discontinue 1 of the 2 drugs in the combination due to adverse events may continue the study with the other combination drug.

Group VII: Pembrolizumab+Docetaxel+Prednisone Experimental Treatment 4 Interventions

Participants with AC mCRPC in Cohort B will receive pembrolizumab 200 mg IV on Day 1 Q3W, docetaxel 75 mg/m\^2 IV on Day 1 Q3W, and prednisone 5 mg tablet PO BID continuously from Day 1 of Cycle 1. Participants will only be permitted to receive a maximum of 10 cycles of docetaxel and prednisone. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.

Group VIII: Pembrolizumab+Carboplatin+Etoposide Experimental Treatment 3 Interventions

Participants with neuroendocrine mCRPC in Cohort I Arm 1 will receive pembrolizumab 200 mg IV on Day 1 Q3W + carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 Q3W + etoposide 100 mg/m\^2 IV on Days 1, 2, and 3 Q3W. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Treatment with carboplatin+etoposide will continue for a maximum of 4 cycles (up to 2.8 months). Participants who must discontinue 1 or 2 of the 3 drugs due to adverse events in the combination may continue the study with the other combination drug/drugs.

Group IX: Pembrolizumab+Belzutifan Experimental Treatment 2 Interventions

Participants with AC mCRPC in Cohort J will receive belzutifan 120mg QD in the initial cohort. If an efficacy signal is detected in this arm based on a totality of evidence, Cohort J may be expanded further where participants will be randomized 1:1 to receive either belzutifan 120 mg QD or belzutifan 120 mg QD and pembrolizumab 200 mg Q3W. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.

Group X: Pembrolizumab+Abiraterone+Prednisone Experimental Treatment 3 Interventions

Participants with AC mCRPC in Cohort D will receive pembrolizumab 200 mg IV on Day 1 Q3W, abiraterone acetate 1000 mg PO QD and prednisone 5 mg tablet PO BID continuously from Day 1 of Cycle 1. Treatment with pembrolizumab will continue for a maximum of 35 cycles (up to 2 years) or until progression. Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.

Group XI: Carboplatin+Etoposide Experimental Treatment 2 Interventions

Participants with neuroendocrine mCRPC in Cohort I Arm 2 will receive carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 Q3W + etoposide 100 mg/m\^2 IV on Days 1, 2, and 3 Q3W. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression. Treatment with carboplatin+etoposide will continue for a maximum of 4 cycles (up to 2.8 months). Participants who must discontinue 1 of the 2 drugs due to adverse events in the combination may continue the study with the other combination drug.

Group XII: Belzutifan Experimental Treatment 1 Intervention

Participants with AC mCRPC in Cohort J will receive belzutifan 120mg QD in the initial cohort. If an efficacy signal is detected in this arm based on a totality of evidence, Cohort J may be expanded further where participants will be randomized 1:1 to receive either belzutifan 120 mg QD or belzutifan 120 mg QD and pembrolizumab 200 mg Q3W. Treatment will continue for a maximum of 35 cycles (up to 2 years) or until progression.

Abiraterone acetate is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Zytiga for:

• Metastatic castration-resistant prostate cancer

Approved in United States as Zytiga for:

• Metastatic castration-resistant prostate cancer
• High-risk metastatic hormone-sensitive prostate cancer

Approved in Canada as Zytiga for:

• Metastatic castration-resistant prostate cancer

Approved in Japan as Zytiga for:

• Metastatic castration-resistant prostate cancer

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

The KEYNOTE-991 trial is a phase III study involving approximately 1232 patients with metastatic hormone-sensitive prostate cancer, testing the combination of pembrolizumab and enzalutamide with androgen deprivation therapy to see if it improves survival and delays disease progression.

This trial aims to explore the potential synergistic effects of combining a PD-1 inhibitor (pembrolizumab) with standard hormonal therapy (enzalutamide), which could lead to new treatment options for patients who typically develop resistance to current therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

KEYNOTE-991: pembrolizumab plus enzalutamide and androgen deprivation for metastatic hormone-sensitive prostate cancer. Gratzke, C., Kwiatkowski, M., De Giorgi, U., et al.[2023]

In a study of 71,606 men with castration-resistant prostate cancer, 7% received emerging therapies like abiraterone and enzalutamide, indicating these treatments are becoming common in clinical practice.

Among those receiving emerging therapies, 61% also used denosumab or zoledronic acid, particularly in patients with bone metastases, highlighting a trend towards combined treatment approaches for better management of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Observational Study of Concomitant Use of Emerging Therapies and Denosumab or Zoledronic Acid in Prostate Cancer. Liede, A., Wade, S., Lethen, J., et al.[2019]

In a study involving 102 patients with metastatic castration-resistant prostate cancer (mCRPC) who had previously failed abiraterone treatment, the combination of pembrolizumab and enzalutamide showed a confirmed prostate-specific antigen (PSA) response rate of only 24%, indicating limited antitumor activity.

The treatment was associated with a high incidence of treatment-related adverse events (92%), including severe reactions in 43% of patients, but the safety profile was consistent with the known effects of each drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab and Enzalutamide in Patients with Abiraterone Acetate-Pretreated Metastatic Castration-Resistant Prostate Cancer: Cohort C of the Phase 1b/2 KEYNOTE-365 Study. Yu, EY., Berry, WR., Gurney, H., et al.[2023]

In a phase II trial involving men with metastatic castration-resistant prostate cancer (mCRPC) who were progressing on enzalutamide, the anti-PD-1 antibody pembrolizumab showed unexpected antitumor activity, with three out of ten patients achieving significant reductions in prostate-specific antigen (PSA) levels.

The presence of immune cell infiltrates and PD-L1 expression in tumor biopsies from responders suggests that certain biological markers may predict the effectiveness of PD-1 inhibitors in prostate cancer, warranting further investigation into this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early evidence of anti-PD-1 activity in enzalutamide-resistant prostate cancer. Graff, JN., Alumkal, JJ., Drake, CG., et al.[2022]

Five new agents have been approved for treating metastatic, castration-resistant prostate cancer, with four being non-chemotherapeutic and generally well tolerated, although they can still cause toxicities that may affect elderly patients.

The review highlights the importance of considering disease burden, comorbid conditions, and potential drug-drug interactions when selecting therapies for elderly patients, as the clinical trial populations often differ from real-world patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapeutic management of metastatic, castration-resistant prostate cancer in the elderly: focus on non-chemotherapy agents. Graff, JN., Beer, TM.[2022]

In a study of 54 men with advanced prostate cancer treated with pembrolizumab, about 55% experienced stabilization or a decline in PSA levels, indicating modest efficacy of the treatment.

Men who started pembrolizumab with lower PSA levels and fewer bone metastases had a higher likelihood of responding to the treatment, suggesting that earlier intervention may improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real World Experience With Pembrolizumab in Recurrent or Advanced Prostate Cancer. Higa, J., Wilenius, K., Savino, S., et al.[2021]

In a network meta-analysis of four trials involving treatments for castration-resistant, docetaxel-resistant metastatic prostate cancer, no significant differences in overall survival were found among abiraterone acetate, enzalutamide, cabazitaxel, and Radium-223.

However, enzalutamide showed a significant advantage over the other treatments in delaying PSA progression, suggesting it may be more effective in managing disease progression despite similar overall survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Metastatic, Castration-resistant, Docetaxel-resistant Prostate Cancer: A Systematic Review of Literature With a Network Meta-analysis of Randomized Clinical Trials. Tassinari, D., Cherubini, C., Roudnas, B., et al.[2021]

The KEYNOTE-641 study is a Phase III clinical trial designed to evaluate the safety and efficacy of combining the PD-1 inhibitor pembrolizumab with enzalutamide in men with metastatic castration-resistant prostate cancer (mCRPC).

This trial aims to determine if the combination therapy can improve outcomes compared to enzalutamide alone, addressing the need for more effective treatments in a patient population with a median survival of about 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

KEYNOTE-641: a Phase III study of pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer. Graff, JN., Liang, LW., Kim, J., et al.[2021]

A 58-year-old patient with metastatic castration-resistant prostate cancer and microsatellite instability-high showed significant clinical improvement after treatment with pembrolizumab, including decreased prostate-specific antigen levels and reduced lymph node size.

This case suggests that pembrolizumab could be an effective treatment option for patients with microsatellite instability-high in castration-resistant prostate cancer, despite its rarity, marking a potential new avenue for therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for a patient with metastatic castration-resistant prostate cancer with microsatellite instability-high. Fujiwara, M., Komai, Y., Yuasa, T., et al.[2022]

In a study of 206 men with previously untreated metastatic castration-resistant prostate cancer (mCRPC) harboring PD-L1 staining, the combination of pembrolizumab (PEM) and enzalutamide (ENZ) significantly improved overall survival (25.1 months) and progression-free survival (6.1 months) compared to PEM alone (18.3 months and 4.9 months, respectively).

While the combination treatment had a higher rate of adverse events (72% for PE vs. 45.3% for PA), these side effects, including fatigue and musculoskeletal issues, were generally manageable, indicating a favorable safety profile for the combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab with or without enzalutamide in selected populations of men with previously untreated metastatic castration-resistant prostate cancer harbouring programmed cell death ligand-1 staining: a retrospective study. Lin, H., Liu, Q., Zeng, X., et al.[2023]

In the phase II KEYNOTE-199 study involving 258 patients with metastatic castration-resistant prostate cancer (mCRPC), pembrolizumab demonstrated modest antitumor activity, with objective response rates of 5% in PD-L1-positive patients and 3% in PD-L1-negative patients, indicating some effectiveness in this challenging population.

The treatment was generally well-tolerated, with 60% of patients experiencing treatment-related adverse events, but only 5% discontinuing due to these events, suggesting that pembrolizumab has an acceptable safety profile while providing encouraging overall survival estimates, particularly in patients with bone-predominant disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study. Antonarakis, ES., Piulats, JM., Gross-Goupil, M., et al.[2021]

Pembrolizumab, an FDA-approved immune checkpoint inhibitor, has shown promising responses in specific subgroups of patients with metastatic castration-resistant prostate cancer (mCRPC), despite most trials not meeting their primary endpoints.

Innovative combination therapies involving pembrolizumab with other treatments, such as radioligands and DNA vaccines, are currently being explored and show potential for improving patient survival in mCRPC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab in mCRPC - Combination therapies as breakthrough to success? Plas, S., Pircher, A., Heidegger, I.[2023]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.TPS250

Phase 1b/2 study of pembrolizumab plus belzutifan and ... The anti–PD-1 antibody pembrolizumab has been shown to have activity as monotherapy and combination therapy in pts with mCRPC.

2. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/belzutifan-merck-metastatic-castration-resistant-prostate-cancer-mcrpc-likelihood-of-approval/

Belzutifan by Merck for Metastatic Castration-Resistant ... According to GlobalData, Phase II drugs for Metastatic Castration-Resistant Prostate Cancer (mCRPC) have a 33% phase transition success rate ( ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456924001755

Belzutifan Efficacy and Tolerability in Patients with ... A study at MD Anderson Cancer Center followed 22 patients who were treated with belzutifan, and found that it worked to control the cancer for almost 9 mo and ...

4. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/17588359251317846

Belzutifan for the treatment of renal cell carcinoma Of 61 enrolled patients, belzutifan treatment achieved an ORR in RCC tumors of 49% and 92% of patients had a reduction in their RCC target ...

5. youtube.com youtube.com/watch?v=9Kh8gitLZME

Assessing the real-world outcomes and safety of belzutifan in ... However, real-world data on its use and efficacy are lacking. A study at CU Cancer Center aims to assess the outcomes and safety of belzutifan ...

6. urologytimes.com urologytimes.com/view/eric-jonasch-md-shares-pooled-safety-data-on-belzutifan-in-advanced-rcc

Eric Jonasch, MD, shares pooled safety data on belzutifan ... Belzutifan, a HIF-2α inhibitor, is approved for von Hippel-Lindau disease and advanced renal cell carcinoma, with a focus on its safety profile.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.10605

Long-term safety of belzutifan in von Hippel-Lindau ... Conclusions: These findings provide long-term safety data on belzutifan in VHL. While AE were common, dose reductions were effective in ...

8. academic.oup.com academic.oup.com/oncolo/advance-article/doi/10.1093/oncolo/oyaf274/8249253?searchresult=1

The safety profile of belzutifan in renal tumors: real-world data ... The LITESPARK-004 and LITESPARK-005 trials demonstrated the clinical efficacy and safety of belzutifan in VHL disease and spRCC. ... Prostate Cancer treated with ...

9. cancertherapyadvisor.com cancertherapyadvisor.com/reports/belzutifan-safety-profile-generally-manageable/

Belzutifan Has “Generally Manageable” Safety Profile Belzutifan has a “generally manageable” safety profile in patients with RCC, with a relatively low rate of treatment discontinuation.