What side effects are associated with this type of intervention?

Immune checkpoint inhibitors, such as Durvalumab, pembrolizumab, nivolumab, and ipilimumab, commonly cause immune-related adverse events (irAEs). These include dermatologic reactions like rash and pruritus, gastrointestinal issues such as colitis and diarrhea, endocrine disorders including thyroiditis and adrenal insufficiency, and pulmonary complications like pneumonitis. While severe side effects can occur, they are less common and often manageable with corticosteroids or other immunosuppressive therapies.

What prior FDA approvals exist?

The FDA has approved several PD-1 and PD-L1 inhibitors for cancer treatment. Pembrolizumab (Keytruda) and Nivolumab (Opdivo) are PD-1 inhibitors approved for various cancers, including metastatic non-small cell lung cancer (NSCLC) and melanoma. Atezolizumab (Tecentriq) and Avelumab (Bavencio) are PD-L1 inhibitors approved for cancers such as urothelial carcinoma and Merkel cell carcinoma. These drugs work by blocking the PD-1/PD-L1 pathway, enhancing the immune system's ability to fight cancer.

What other types of research exist?

Promising alternatives to Durvalumab for cancer treatment include: 1) Nivolumab (PD-1 inhibitor) often combined with Ipilimumab (CTLA-4 inhibitor) for enhanced efficacy, 2) Pembrolizumab (PD-1 inhibitor) which has shown effectiveness in various cancers, and 3) Nivolumab combined with Relatlimab (LAG-3 inhibitor) which has demonstrated promising results in metastatic melanoma. These alternatives offer different mechanisms of action and have been effective in clinical trials.

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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

Must not have

Additional exclusion criteria for the ROSY-D sub-study: 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)

Permanent discontinuation from the parent study due to toxicity or disease progression

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

No Placebo-Only Group

Pivotal Trial

Summary

This trial continues to provide Durvalumab to patients who are still benefiting from it after a previous study. Durvalumab helps the immune system recognize and fight cancer cells by blocking a specific protein. Durvalumab is an immune checkpoint inhibitor that has been studied in combination with other drugs for treating various cancers.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have severe side effects from a previous study that haven't resolved.

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I have ongoing side effects that require more than 10 mg of prednisone daily.

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I am not taking any medications that are not allowed in the study.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to follow up at 90 days after the last dose of study drug. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

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.

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

~3750

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include immune checkpoint inhibitors, targeted therapies, and chemotherapy. Immune checkpoint inhibitors like Durvalumab block the PD-L1 protein, enabling the immune system to attack cancer cells. Targeted therapies inhibit specific genetic mutations or proteins essential for cancer growth, while chemotherapy uses cytotoxic drugs to kill rapidly dividing cells. Understanding these mechanisms helps in choosing the most effective treatment, improving patient outcomes and reducing side effects.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.