CancerPhase 3ROSY-DNCT05303532
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab
A Phase 3 study testing Durvalumab in people with Cancer, run by AstraZeneca at 123 sites in 31 countries.
Trial summary
The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer
- What is being tested?
- Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 123 sitesin 31 countries
- Study dates
- 19 Apr 2022to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Core Protocol inclusion criteria are:
- 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.
- Patient can receive durvalumab as a fixed dose of 1500 mg quarterly 4 weeks at study entry.
- There are no additional inclusion criteria for the ROSY-D sub-study.
Who cannot join
- The Core Protocol exclusion criteria are.
- Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
- Currently receiving treatment with any prohibited medication(s).
- Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Permanent discontinuation from the parent study due to toxicity or disease progression (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [example: Response Evaluation Criteria in Solid Tumours] progression or clinical progression).
- Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation.
Show all 10Show fewer
- The additional exclusion criteria for the ROSY-D sub-study are:
- Active infection including Coronavirus disease 2019 (Polymerase chain reaction confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive Hepatitis B virus (HBV) surface antigen result), hepatitis C, or Human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies).
- Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy.
- Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of ≤ 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.
Trial locations and contacts
123 sites in 31 countries. Contact the study team or a site near you to ask about taking part.
123 sites in 31 countries
France14 sites
Research Site
Besançon, 25030
Research Site
Bordeaux, 33076
Research Site
Brest, 29200
Research Site
Dijon, 21079
Research Site
Lyon, 69373
Research Site
Marseille, 13005
Research Site
Montpellier, 34090
Research Site
Rennes, 35042
Research Site
Rouen, 76031
Research Site
Saint-Herblain, 44805
Research Site
Strasbourg, 67200
Research Site
Toulouse, 31059
Research Site
Tours, 37044
Research Site
Villejuif, 94805
China10 sites
Research Site
Beijing, 100142
Research Site
Changsha, 410013
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310009
Research Site
Nanjing, 210009
Research Site
Shanghai, 200030
Research Site
Shenyang, 110042
Research Site
Wenzhou, 325000
Research Site
Xi'an, 710061
Research Site
Xiamen, 361003
Italy10 sites
Research Site
Arezzo, 52100
Research Site
Bari, 70124
Research Site
Catania, 95126
Research Site
Meldola, 47014
Research Site
Milan, 20141
Research Site
Modena, 41125
Research Site
Padova, 35128
Research Site
Pisa, 56126
Research Site
Roma, 00128
Research Site
Roma, 00152
Japan8 sites
Research Site
Bunkyō City, 113-8677
Research Site
Fukuoka, 812-8582
Research Site
Kanazawa, 920-8641
Research Site
Kōtoku, 135-8550
Research Site
Nagoya, 466-8560
Research Site
Okayama, 700-8607
Research Site
Saga, 840-8571
Research Site
Sunto-gun, 411-8777
Poland8 sites
Research Site
Bialystok, 15-027
Research Site
Bydgoszcz, 85-796
Research Site
Elblag, 02-300
Research Site
Lodz, 90-302
Research Site
Lodz, 93-513
Research Site
Olsztyn, 10-357
Research Site
Szczecin, 71-730
Research Site
Warsaw, 02-781
Russia7 sites
Research Site
Moscow, 105229
Research Site
Moscow, 115478
Research Site
Nizhny Novgorod, 603001
Research Site
Novosibirsk, 630108
Research Site
Omsk, 644013
Research Site
Saint Petersburg, 196603
Research Site
Saint Petersburg, 197758
Spain7 sites
Research Site
Barcelona, 08025
Research Site
Barcelona, 08035
Research Site
Girona, 17007
Research Site
Madrid, 28046
Research Site
Marbella, 29603
Research Site
Santiago de Compostela, 15706
Research Site
Valencia, 46009
Turkey (Türkiye)6 sites
Research Site
Ankara, 06010
Research Site
Ankara, 06590
Research Site
Ankara, 06800
Research Site
Bursa, 16059
Research Site
Istanbul, 34098
Research Site
Izmir, 35100
Ukraine6 sites
Research Site
Chernivtsi, 58013
Research Site
Dnipro, 49102
Research Site
Ivano-Frankivsk, 76018
Research Site
Kyiv, 88014
Research Site
Uzhhorod, 88014
Research Site
Vinnytsia, 21029
South Korea5 sites
Research Site
Busan, 49241
Research Site
Gwangju, 61469
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06351
Taiwan5 sites
Research Site
Taichung, 404
Research Site
Taichung, 40705
Research Site
Tainan, 704
Research Site
Taipei, 112
Research Site
Taoyuan, 333
United States3 sites
Research Site
Denver, Colorado, 80218
Research Site
Memphis, Tennessee, 38120
Research Site
Newport Beach, California, 92663
Canada3 sites
Research Site
Kingston, Ontario, K7L 2V7
Research Site
Newmarket, Ontario, L3Y 2P9
Research Site
Toronto, Ontario, M5G 2M9
Germany3 sites
Research Site
Gütersloh, 33332
Research Site
Münster, 48149
Research Site
Oldenburg, 26121
Hungary3 sites
Research Site
Budapest, 1083
Research Site
Győr, 9024
Research Site
Székesfehérvár, 8000
Thailand3 sites
Research Site
Bangkok, 10330
Research Site
Chiang Mai, 50200
Research Site
Hat Yai, 90110
Vietnam3 sites
Research Site
Hanoi, 100000
Research Site
Hồ Chí Minh, 700000
Research Site
Ho Chi Minh City, 70000
Brazil2 sites
Research Site
Barretos, 14784-400
Research Site
São José do Rio Preto, 15090-000
United Kingdom2 sites
Research Site
London, EC1A 7BE
Research Site
Sheffield, S10 2SJ
About this study
Official title: ROSY-D: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.
Read the detailed description
ROSY-D is an open label, non-randomised, multicentre, international trial for patients who have completed a parent study using durvalumab and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria.
- Conditions
- Cancer
- Being tested
- Durvalumab
- Keywords
- Cancer, Oncology, Clinically Benefit, Roll Over StudY, Durvalumab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab | Experimental | Participants will receive durvalumab. Receives: Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
To monitor safety and tolerability of continuous study treatment to patients who continue to benefit at the end of the clinical trial by measuring the primary outcome of Serious Adverse Events (SAEs).
Measured: From baseline up to follow up at 90 days after the last dose of study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start19 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303532
- Sponsor's protocol ID
- D4191C00137
- Other IDs
- 2021-003031-29
- Acronym
- ROSY-D
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROSY-D: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
- ClinicalTrials.gov ID
- NCT05303532
- Acronym / sponsor ID
- ROSY-D / D4191C00137
- Conditions
- Cancer
- Keywords
- Cancer, Oncology, Clinically Benefit, Roll Over StudY, Durvalumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.
Detailed description
ROSY-D is an open label, non-randomised, multicentre, international trial for patients who have completed a parent study using durvalumab and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab | Experimental | Drug: DurvalumabParticipants will receive durvalumab. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Patient can receive durvalumab as a fixed dose of 1500 mg quarterly 4 weeks at study entry.
- There are no additional inclusion criteria for the ROSY-D sub-study.
Key exclusion criteria (10 listed)
- The Core Protocol exclusion criteria are.
- Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
- Currently receiving treatment with any prohibited medication(s).
- Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Permanent discontinuation from the parent study due to toxicity or disease progression (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [example: Response Evaluation Criteria in Solid Tumours] progression or clinical progression).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabFixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter. | Drug | Durvalumab |
Primary outcome
Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From baseline up to follow up at 90 days after the last dose of study drug.
To monitor safety and tolerability of continuous study treatment to patients who continue to benefit at the end of the clinical trial by measuring the primary outcome of Serious Adverse Events (SAEs).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Related trials for Cancer
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Not yet recruitingPhase 2
A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia
Cachexia-Anorexia Syndrome, Cachexia; Cancer
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
123 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Durvalumab in people with Cancer, run by AstraZeneca at 123 sites in 31 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 123 sites in France, China, Italy, Japan, Poland and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (time frame: From baseline up to follow up at 90 days after the last dose of study drug.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.