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Continued Durvalumab for Cancer (ROSY-D Trial)
Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to follow up at 90 days after the last dose of study drug.
Awards & highlights
ROSY-D Trial Summary
This trial is for patients who have already participated in a study with the drug Durvalumab and are still benefitting from it, as judged by their doctor.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Durvalumab may cause immune-related reactions such as inflammation in organs, infusion reactions which can include symptoms like fever or chills during administration, fatigue, potential blood disorders, and increased risk of infection.
ROSY-D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to follow up at 90 days after the last dose of study drug.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to follow up at 90 days after the last dose of study drug.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Side effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
ROSY-D Trial Design
1Treatment groups
Experimental Treatment
Group I: DurvalumabExperimental Treatment1 Intervention
Participants will receive durvalumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,725 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have severe side effects from a previous study that haven't resolved.I have ongoing side effects that require more than 10 mg of prednisone daily.I can get the trial drug for free as allowed by my country's laws.I am not taking any medications that are not allowed in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Will this research be able to help elderly patients?
"This trial is open to patients that fall between 18-99 years old. There are 328 other trials for patients under the age of 18 and 3069 for those 65 and older."
Answered by AI
Are there specific restrictions for who can and cannot enroll in this clinical trial?
"Up to 61 patients with non-small cell lung carcinoma (NSCLC) between the ages of 18 and 99 can participate in this research study. Key inclusion criteria are as follows: The patient must provide a signed and dated informed consent form, the patient is currently benefiting from treatment in another trial using an AZ compound or has reached the maximum allowed duration of treatment, and there are no additional inclusion criteria for the ROSY-D sub-study."
Answered by AI
What have been patients' experience with Durvalumab thus far?
"There is both pre-existing data affirming Durvalumab's efficacy and rounds of clinical trials demonstrating its safety, so it received a score of 3."
Answered by AI
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