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Checkpoint Inhibitor

Durvalumab +/− Tremelimumab for Advanced Cancer

Phase 1
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically and/or cytologically confirmed cancer that is advanced / metastatic / recurrent or unresectable and for which no curative therapy exists.
For etoposide/carboplatin regimen, patients must have untreated small cell lung cancer (SCLC).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing the safety of durvalumab, with or without tremelimumab, in combination with chemotherapy for patients with advanced solid tumors.

Who is the study for?
This trial is for adults with advanced solid tumors that can't be cured by surgery or other therapies. They must have recovered from previous treatments, not had severe reactions to similar drugs, and agree to use effective contraception. People with certain autoimmune diseases, untreated heart conditions, or who are pregnant can't join.Check my eligibility
What is being tested?
The study tests the highest tolerable doses of durvalumab alone or combined with tremelimumab alongside standard chemotherapy in patients with incurable solid malignancies. It aims to determine safety and effects on cancer at these doses.See study design
What are the potential side effects?
Durvalumab and tremelimumab may cause immune-related side effects like inflammation in various organs, infusion reactions (symptoms related to drug administration), potential worsening of autoimmune diseases, and possibly increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced, cannot be surgically removed, and cannot be cured.
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I have small cell lung cancer that hasn't been treated yet.
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I have given permission for my tumor sample to be used for research.
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I have recovered from side effects of my previous cancer treatments.
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I can care for myself and am up and about more than 50% of my waking hours.
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I have not received etoposide-carboplatin but may have had other chemotherapy.
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I can start the trial treatment within 2 days of signing up.
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I have not had chemotherapy for my advanced disease.
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I have had cancer treatment with specific antibodies without severe side effects or needing steroids for them.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirm the recommended phase II dose (RP2D) of durvalumab ± tremelimumab in patients receiving standard chemotherapy
Secondary outcome measures
Characterize the immunogenicity of durvalumab ± tremelimumab in patients receiving standard chemotherapy
Abdomen
Number of Participants with treatment-related adverse events as assessed by CTCAE v 4.0

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407
38%
Fatigue
21%
Diarrhea
17%
Pruritus
17%
Maculopapular rash
17%
Anorexia
17%
Nausea
17%
Fever
14%
Rash maculo-papular
14%
Constipation
10%
Itching
10%
Anemia
10%
Abdominal pain
7%
Cough
7%
Dry Skin
7%
Dehydration
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: durvalumab ± tremelimumabExperimental Treatment2 Interventions
durvalumab; Day 1 every 3 weeks or 4 weeks tremelimumab; every 3-6 weeks for a total of 1-6 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tremelimumab
2013
Completed Phase 2
~1550
durvalumab
2017
Completed Phase 2
~400

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
122 Previous Clinical Trials
66,999 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,238 Previous Clinical Trials
288,471,268 Total Patients Enrolled
Rosalyn JuergensStudy ChairJuravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON Canada

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02537418 — Phase 1
Solid Tumors Research Study Groups: durvalumab ± tremelimumab
Solid Tumors Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT02537418 — Phase 1
Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02537418 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many areas is this investigation accessible?

"This medical trial is operating out of CHUM - Hopital Notre-Dame in Montreal, Quebec; Tom Baker Cancer Centre in Calgary, Alberta; and Juravinski Cancer Centre at Hamilton Health Sciences based in Hamilton, Ontario. Additionally, there are 7 other research sites participating as well."

Answered by AI

Is this pioneering trial the inaugural of its kind?

"At present, there are 340 active trials involving durvalumab administered in 1327 cities and 58 countries. These studies first began back in 2007 when AstraZeneca sponsored a Phase 2 drug approval study featuring 37 participants. Since then, 123 more clinical investigations have been conducted around the world."

Answered by AI

What potential risks are associated with durvalumab treatments?

"Due to its Phase 1 status, durvalumab's safety is assessed as a score of 1. This reflects the limited amount of data available on this drug's efficacy and security."

Answered by AI

Has durvalumab been previously tested in other clinical investigations?

"As of today, 340 studies are ongoing looking into durvalumab with 52 trials in Phase 3. Most notably, Cordoba Texas is running the majority of these experiments; however, 13098 other locations around the world have clinical trials for this drug."

Answered by AI

What is the aggregate enrollment rate for this clinical investigation?

"Unfortunately, this clinical trial is no longer accepting patients. Initially added to the database on October 1st 2015 and last updated September 23rd 2022, it has reached its recruitment capacity. However, those seeking alternative trials can choose from a pool of 2339 cancer-focused studies or 340 durvalumab investigations that are actively recruiting participants."

Answered by AI

Are there opportunities for new participants to join this research endeavor?

"Unfortunately, this trial is not accepting participants at the moment. It was first posted on October 1st 2015 and last updated September 23rd 2022. However, if you are looking for other trials in cancer treatment or durvalumab-related research there are currently 2379 and 340 studies respectively actively seeking volunteers."

Answered by AI

What are the primary applications of durvalumab treatment?

"Durvalumab is typically utilized to treat unresectable stage III non-small cell lung cancer, with further efficacy for metastatic urothelial carcinoma and advanced directives."

Answered by AI
~16 spots leftby Mar 2025