Volrustomig + Casdatifan for Kidney Cancer

(eVOLVE-RCC02 Trial)

Not currently recruiting at 26 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Disqualifiers: Brain metastases, COPD, autoimmune disorders, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatments for advanced kidney cancer. Researchers aim to determine how well volrustomig, alone or with casdatifan, works compared to standard treatments nivolumab and ipilimumab. They seek to identify which combination is safest and most effective for individuals with clear cell renal cell carcinoma, a common type of kidney cancer. Participants should have advanced kidney cancer that remains untreated. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in kidney cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that the combination of volrustomig and casdatifan holds promise for safety. Previous studies on casdatifan alone suggest a generally manageable safety profile, with mild and controllable side effects.

For volrustomig, research in patients with advanced kidney cancer indicates good tolerance at a dose of 1,500 mg every three weeks. This dose has yielded positive results, with fewer cases of disease progression.

These findings suggest that the combination of volrustomig and casdatifan could be safe for patients. Since this trial is in an advanced phase, earlier trials have already demonstrated some level of safety, but more data is being collected to confirm this. It is important to consult healthcare providers to understand potential risks and benefits before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments in this study because they offer novel approaches to fighting kidney cancer. Unlike the standard treatments like nivolumab and ipilimumab, which work by blocking specific pathways to enhance the immune response, Volrustomig is a new drug with a potentially different mechanism. It targets pathways that may not be addressed by current therapies, possibly offering a new way to inhibit cancer growth. Additionally, Casdatifan, when combined with Volrustomig, might enhance the effectiveness of the treatment, offering hope for improved outcomes. This new combination could represent a significant advancement in kidney cancer treatment, offering patients new hope for better management of their condition.

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

Research has shown that combining the drugs volrustomig and casdatifan may help treat advanced clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. In this trial, participants in different arms will receive various combinations and dosages of these drugs. Studies have found that casdatifan alone has a 46% success rate, with some patients experiencing complete or partial tumor shrinkage. When used as a first treatment, volrustomig demonstrated a 58% success rate, with more than half of the patients seeing their cancer respond. The combination of these drugs aims to leverage their strengths to improve patient outcomes. With these promising results, this treatment offers hope for those fighting advanced kidney cancer. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with advanced clear cell renal cell carcinoma (ccRCC) who haven't had systemic therapy before. They should be relatively active and healthy, as shown by a Karnofsky Performance Status of at least 70%. Participants must have a tumor that can be measured using CT or MRI scans.

Inclusion Criteria

My kidney cancer diagnosis was confirmed with lab tests.

I am able to care for myself but may not be able to do active work.

My kidney cancer has spread or returned and I haven't had systemic therapy for it.

Exclusion Criteria

Active or prior documented autoimmune or inflammatory disorders

I have brain metastases that cause symptoms.

I have had leptomeningeal disease or spinal cord compression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase Ib Treatment

Participants receive either dose 1 or dose 2 of volrustomig in combination with casdatifan

Approximately 39 months

Phase III Treatment

Participants receive either volrustomig in combination with casdatifan, volrustomig monotherapy, or nivolumab plus ipilimumab

Approximately 67 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Casdatifan
• Ipilimumab
• Nivolumab
• Volrustomig

Trial Overview The study compares the effectiveness and safety of two treatments for kidney cancer. One group receives Volrustomig plus Casdatifan, while another gets Nivolumab combined with Ipilimumab. It's randomized, meaning patients are placed into groups by chance.

How Is the Trial Designed?

Group I: Arm 3B (Volrustomig Dose 1) Experimental Treatment 1 Intervention

Participants will receive dose 1 of volrustomig.

Group II: Arm 3A (Volrustomig Dose X + Casdatifan) Experimental Treatment 2 Interventions

Participants will receive Volrustomig at the dose to be determined in the Phase Ib part of the study, in combination with casdatifan.

Group III: Arm 1B (Volrustomig Dose 2 + Casdatifan) Experimental Treatment 2 Interventions

Participants will receive dose 2 of volrustomig in combination with casdatifan.

Group IV: Arm 1A (Volrustomig Dose 1 + Casdatifan) Experimental Treatment 2 Interventions

Participants will receive dose 1 of volrustomig in combination with casdatifan.

Group V: Arm 3C (Nivolumab + Ipilimumab) Active Control 2 Interventions

Participants will receive nivolumab plus ipilimumab as standard of care treatment.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Arcus Biosciences, Inc.

Industry Sponsor

Trials

44

Recruited

7,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07000149

NCT07000149 | A Study to Investigate the Efficacy and ... The primary purpose of this study is to determine the recommended Phase III dose (RP3D) of volrustomig and measure the efficacy and safety of volrustomig in ...

2. investors.arcusbio.com investors.arcusbio.com/investors-and-media/press-releases/press-release-details/2024/Arcus-Biosciences-Announces-Clinical-Trial-Collaboration-Agreement-to-Evaluate-Casdatifan-in-Combination-with-Volrustomig-in-Renal-Cell-Carcinoma/default.aspx

Press Release Details If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, ...

3. urotoday.com urotoday.com/conference-highlights/esmo-2023/esmo-2023-kidney-cancer/147556-esmo-2023-medi5752-volrustomig-a-novel-pd-1-ctla-4-bispecific-antibody-in-the-first-line-1l-treatment-of-65-patients-pts-with-advanced-clear-cell-renal-cell-carcinoma-arcc.html

ESMO 2023: MEDI5752 (Volrustomig), a Novel PD-1/CTLA ... In the 1st line ccRCC setting, 1,500 mg administered every 3 weeks has promising efficacy (ORR: 58%, progressive disease <10%), but dosing is ...

4. urologytimes.com urologytimes.com/view/casdatifan-shows-safety-efficacy-as-monotherapy-in-late-line-metastatic-ccrcc

Casdatifan shows safety, efficacy as monotherapy in late- ... The median time to response was 2.6 months and 2.8 months, respectively. Data also showed a disease control rate of 84% (95% CI, 66 to 95) in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11954509/

Emerging innovative treatment strategies for advanced clear ... This article reviews key findings that have transformed the way we understand and treat metastatic renal cell carcinoma and highlights novel treatment ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)01950-6/fulltext

1883MO MEDI5752 (volrustomig), a novel PD-1/CTLA-4 ... A novel PD-1/CTLA-4 bispecific antibody, in the first-line (1L) treatment of 65 patients (pts) with advanced clear cell renal cell carcinoma (aRCC).

7. kidneycancer.org kidneycancer.org/trial/a-study-to-investigate-the-efficacy-and-safety-of-volrustomig-%C2%B1-casdatifan-vs-nivolumab-ipilimumab-as-1l-treatment-for-advanced-ccrcc/

A Study to Investigate the Efficacy and Safety of ... This is a Phase Ib/III, randomized, multicenter, global study evaluating the efficacy and safety of volrustomig in combination with casdatifan for the first- ...

8. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-volrustomig-and-axitinib-for-patients-with-advanced-kidney-cancer/

Study on the Safety and Effects of Volrustomig and Axitinib ... This study is investigating the safety and efficacy of the combination of MEDI5752, lenvatinib, and axitinib in the treatment of Advanced Renal Cell ...