Continued Durvalumab for Cancer

(ROSY-D Trial)

Enrolling by invitation at 179 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: Durvalumab

Must not be taking: Prohibited medications

Disqualifiers: Active infection, HIV, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Indefinite

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the continued use of durvalumab, a medication, to determine if it still benefits cancer patients who used it in a previous study. The goal is to assess whether patients who responded well to durvalumab can continue to improve by remaining on the treatment. Ideal participants are those who took durvalumab in an earlier study and continue to benefit without serious side effects. As a Phase 3 trial, this study represents the final step before FDA approval, giving participants the opportunity to contribute to the potential approval of durvalumab for broader use.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any prohibited medications while participating. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that Durvalumab is likely to be safe for humans?

Research has shown that durvalumab is generally safe for patients with various solid cancers. In several studies, most participants did not experience severe side effects, indicating it was well-tolerated. For instance, when combined with tremelimumab, durvalumab maintained a manageable safety profile, suggesting that side effects were not too serious or difficult to manage.

One study focused on patients with muscle-invasive bladder cancer, a type that spreads into the muscle wall. It found that using durvalumab with other treatments did not cause unexpected safety issues. Another study examined individuals with advanced non-small-cell lung cancer who had not received prior treatment. It found that durvalumab was safe, and participants could handle the treatment without major problems.

Overall, these studies suggest that durvalumab is a safe option for many cancer patients. However, like any treatment, some risks may exist, and discussing these with a doctor is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Durvalumab is unique because it is an immunotherapy drug that works by targeting and blocking the PD-L1 protein on cancer cells. This action helps the immune system recognize and attack cancer cells more effectively. Unlike traditional chemotherapy, which directly kills both cancerous and healthy cells, durvalumab boosts the body's own defenses specifically against cancer, potentially leading to fewer side effects. Researchers are excited about this treatment because it offers a promising approach to harnessing the immune system to target cancer more precisely.

What is the effectiveness track record for Durvalumab in cancer treatment?

Research has shown that durvalumab, a treatment for various solid cancers, yields promising results. One study found that durvalumab reduced the risk of death by 25% compared to standard treatments. Another study found that among patients who responded well to durvalumab, six out of seven maintained their positive response for 12 months or more. Additionally, the overall survival rates at six and twelve months were 62% and 42%, respectively. These findings suggest that durvalumab may be effective for patients who continue treatment after experiencing previous benefits. Participants in this trial will receive durvalumab to further evaluate its effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for patients who have seen benefits from Durvalumab in a previous cancer study and are still benefiting at the end of that study. They must be willing to use effective birth control, not have unresolved severe side effects or infections like COVID-19, hepatitis B/C, HIV, and cannot be on prohibited medications.

Inclusion Criteria

There are no additional inclusion criteria for the ROSY-D sub-study.

Provision of signed and dated, written Informed Consent Form (ICF)

Patient is currently deriving clinical benefit, as judged by the investigator, from continued treatment in an AstraZeneca parent study using an AstraZeneca compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study's protocol

Exclusion Criteria

I do not have an active infection such as COVID-19, tuberculosis, hepatitis B or C, or HIV.

I was removed from a previous study because of side effects or my disease got worse.

I am not willing to use birth control during and up to 3 months after the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive durvalumab continuously as long as they derive clinical benefit

Indefinite

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Durvalumab

Trial Overview The ROSY-D trial continues providing Durvalumab to those who benefited from it in prior studies. It's designed for patients whose parent trials ended but are still seeing positive effects without significant side effects or disease progression.

How Is the Trial Designed?

Group I: Durvalumab Experimental Treatment 1 Intervention

Participants will receive durvalumab.

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

Published Research Related to This Trial

Durvalumab, an immunotherapy drug for non-small cell lung cancer (NSCLC), has shown significant activity and acceptable tolerability, especially in patients with at least 25% PD-L1 tumor expression, and has been established as a standard treatment following chemoradiation based on the PACIFIC study results.

While durvalumab is effective in wild-type EGFR and ALK patients, its efficacy is lower in those with EGFR mutations or ALK-positive status, highlighting the need for ongoing research into combination therapies and the management of treatment-related toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durvalumab for the treatment of non-small cell lung cancer. Mezquita, L., Planchard, D.[2019]

Durvalumab, a PD-L1 inhibitor, has been shown to be safe for patients with various solid tumors, with common side effects including pruritus and fatigue, based on a meta-analysis of 17 studies involving 1,529 patients.

Higher levels of PD-L1 expression in tumors are linked to better treatment responses to durvalumab, indicating that PD-L1 could serve as a useful biomarker for predicting the drug's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of durvalumab (MEDI4736) in various solid tumors. Yang, H., Shen, K., Zhu, C., et al.[2022]

Durvalumab is an FDA-approved monoclonal antibody that enhances T-cell responses against cancer by blocking the PD-L1 pathway, specifically for patients with advanced urothelial carcinoma who have progressed after platinum-based chemotherapy.

The drug is currently being tested in phase III trials for various cancers, including lung and head and neck cancers, indicating its potential broad application in oncology beyond urothelial carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durvalumab: First Global Approval. Syed, YY.[2022]

In the phase III PACIFIC trial, durvalumab significantly improved overall survival (OS) and progression-free survival (PFS) in patients with unresectable stage III non-small-cell lung cancer after chemoradiotherapy, with a 5-year OS rate of 42.9% compared to 33.4% for placebo.

The updated analyses, with a median follow-up of 34.2 months, showed that durvalumab continues to provide durable benefits, establishing a new standard of care for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. Spigel, DR., Faivre-Finn, C., Gray, JE., et al.[2022]

Durvalumab, a PD-L1 blocking antibody, has shown clinical efficacy and a manageable safety profile in treating advanced non-small-cell lung cancer, especially in patients with ≥25% PD-L1 expression.

The drug is being evaluated in various treatment settings, including as a monotherapy and in combination with other therapies, showing promising results particularly after chemoradiation, although lower response rates were noted in patients with EGFR and ALK mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durvalumab in non-small-cell lung cancer patients: current developments. Mezquita, L., Planchard, D.[2018]

The combination of MEDI0680 and durvalumab was found to be safe and tolerable in patients with advanced clear-cell renal cell carcinoma, but it did not show improved efficacy compared to nivolumab alone, with objective response rates of 16.7% for the combination and 23.8% for nivolumab.

Both treatment groups had a median progression-free survival of 3.6 months, and a notable percentage of patients (23.8% in the combination group) discontinued treatment due to adverse events, highlighting the need for careful monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. Voss, MH., Azad, AA., Hansen, AR., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6038862/

Safety and efficacy of durvalumab (MEDI4736) in various ... Durvalumab is safe in patients with many solid cancers and, in combination with tremelimumab, it has a tolerable safety profile and is associated with improved ...

2. esmoopen.com esmoopen.com/article/S2059-7029(24)00556-8/fulltext

215TiP A phase II study of durvalumab (MEDI 4736) ... DURVALUNG study aims to evaluate the efficacy of durvalumab maintenance specifically in frail LD-SCLC pts who have not progressed following concomitant or ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.778

Feasibility and safety results from RAD-IO Recent phase 3 results with peri-operative durvalumab show a 25% reduction in the risk of death compared to standard of care. Methods: RADIO is ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04621370

Study Details | NCT04621370 | A Trial of Durvalumab ... In this phase II trial, the investigators plan to evaluate the potential treatment efficacy of anti-PD-L1 systemic anticancer treatment, durvalumab, alongside ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)44576-6/fulltext

Updated safety and efficacy of durvalumab (MEDI4736), an ... Among seven responders, six patients had DoR for >= 12 months with longest DoR being 19.8 months. Six and 12-month OS is 62% (95% CI 48, 74) and 42% (95% CI 27, ...

6. asco.org asco.org/abstracts-presentations/ABSTRACT163695

Safety and clinical activity of durvalumab (MEDI4736), an ... Safety and clinical activity of durvalumab (MEDI4736), an anti-PD-L1 antibody, in treatment-naïve patients with advanced non‒small-cell lung cancer. download.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02087423?term=AREA%5BBasicSearch%5D(AREA%5BInterventionSearch%5D(DURVALUMAB%20OR%20MEDI4736%20OR%20MEDI-4736%20OR%20Imfinzi))&rank=10

A Global Study to Assess the Effects of MEDI4736 ... This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736 (Durvalumab), in patients with Locally Advanced or ...