Durvalumab (+/- Tremelimumab) for Cancer
Recruiting in Palo Alto (17 mi)
+13 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Canadian Cancer Trials Group
Must not be taking: Immunosuppressants, Biologics
Disqualifiers: Cardiovascular conditions, Active infection, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?I238A: The purpose of this study is to find out what effects being treated with durvalumab has on cancer. The researchers doing this study also want to evaluate if prednisone (a type of steroid), when given together with durvalumab, can reduce any side effects.
I238B: The purpose of this study is to allow patients previously enrolled on a completed CCTG trial to continue treatment with durvalumab (+/- tremelimumab)
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must have completed corticosteroid therapy at least 28 days before joining the study, and you should not be on any other investigational drugs or anti-cancer therapy concurrently.
Is the combination of Durvalumab and Tremelimumab safe for humans?
The combination of Durvalumab and Tremelimumab has been studied in various cancers and is generally considered to have a tolerable safety profile, though it may cause some side effects like reduced appetite and diarrhea. Serious side effects (Grade 3 or higher) occurred in about 32.6% of patients using the combination, compared to 23.8% with Durvalumab alone.
12345What makes Durvalumab (+/- Tremelimumab) unique compared to other cancer drugs?
Durvalumab, often combined with Tremelimumab, is unique because it works by blocking a protein called PD-L1, which helps cancer cells hide from the immune system, allowing the body's natural defenses to better attack the cancer. This mechanism is different from traditional chemotherapy, which directly kills cancer cells, and offers a novel approach for treating certain cancers.
678910Eligibility Criteria
This trial is for cancer patients in Canada who had a positive response to initial immunotherapy but stopped due to immune-related side effects, which have since resolved. They must not have received certain other treatments post-immunotherapy and should be stable enough with a life expectancy of at least 12 weeks.Inclusion Criteria
I stopped immunotherapy due to side effects, which are now mild or gone, and I finished steroids over 28 days ago.
I will not donate blood during or for 3 months after the study.
My cancer responded well to initial immunotherapy and I haven't had immunotherapy for at least 6 months.
+12 more
Exclusion Criteria
I have not received a live vaccine within 30 days before joining or before getting durvalumab.
I needed special medication to manage side effects from immune therapy.
I have an active stomach ulcer or inflammation.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive durvalumab, with or without prednisone, to evaluate its effects on cancer and manage side effects
24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the effect of Durvalumab on cancer, alone or with Tremelimumab, after prior checkpoint therapy was discontinued due to toxicity. It also examines if Prednisone can reduce side effects when combined with Durvalumab.
3Treatment groups
Active Control
Group I: Cohort 2: Standard Risk - Arm AActive Control2 Interventions
Group II: Cohort 1: High RiskActive Control2 Interventions
Group III: Cohort 2: Standard Risk - Arm BActive Control2 Interventions
Durvalumab is already approved in European Union, United States, Japan for the following indications:
🇪🇺 Approved in European Union as Imfinzi for:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
🇺🇸 Approved in United States as Imfinzi for:
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
🇯🇵 Approved in Japan as Imfinzi for:
- Not specified in provided sources
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
BCCA - KelownaKelowna, Canada
BCCA - VancouverVancouver, Canada
Juravinski Cancer Centre at Hamilton Health SciencesHamilton, Canada
BCCA - Cancer Centre for the Southern InteriorKelowna, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Canadian Cancer Trials GroupLead Sponsor
AstraZenecaIndustry Sponsor
References
Adverse Events and Tolerability of Combined Durvalumab and Tremelimumab versus Durvalumab Alone in Solid Cancers: A Systematic Review and Meta-Analysis. [2023]Background: Recently, the combination of durvalumab and tremelimumab, two immune checkpoint inhibitors, for the treatment of different types of cancers has been considered; however, its overall effects, including its safety, are still unclear and need to be further investigated. Objectives: The aim of the present systematic review and meta-analysis was to investigate the safety and tolerability of this combination of drugs. Methods: A systematic review of the literature, based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement, was conducted by employing online electronic databases and the American Society of Clinical Oncology (ASCO) Meeting Library. The selection of eligible publications was made following a staged screening and selection process. The software RevMan 5.4 was used to run the quantitative analysis and forest plots, while the Cochrane tool was employed for risk of bias assessment. Results: From the retrieved 157 results, 9 randomized controlled trials involving 3060 patients were included. By comparing the combination of durvalumab and tremelimumab vs. durvalumab monotherapy, it was observed that: adverse events (AEs) ≥ Grade 3 incidence was 32.6% (536/1646) vs. 23.8% (336/1414) (Z = 2.80; p = 0.005; risk ratio (RR) = 1.44), reduced appetite incidence was 10.8% (154/1427) vs. 8.3% (108/1305) (Z = 2.26; p = 0.02; RR = 1.31), diarrhea was reported in 15.6% (229/1473) vs. 8.1% (110/1352) (Z = 5.90; p
Safety and efficacy of durvalumab (MEDI4736) in various solid tumors. [2022]The prominent immune checkpoint molecule, programmed cell death ligand-1 (PD-L1), is the object of increasing attention. Here, we report a meta-analysis investigating the safety and efficacy of durvalumab (MEDI4736), an inhibitor of PD-L1, in various solid tumors.
Durvalumab: First Global Approval. [2022]Intravenous durvalumab (Imfinzi™; AstraZeneca) is a fully human monoclonal antibody that blocks programmed cell death ligand-1 binding to its receptors (PD-1 and CD80), resulting in enhanced T-cell responses against cancer cells. The US FDA has granted durvalumab accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Durvalumab ± tremelimumab is under phase III clinical trials in urothelial carcinoma, non-small cell lung cancer, small cell lung cancer and head and neck squamous cell carcinoma. The drug is also being evaluated in phase I or II clinical trials in a wide range of solid tumours and haematological malignancies. This article summarizes the milestones in the development of durvalumab leading to this first approval for urothelial carcinoma.
Durvalumab and tremelimumab combination therapy versus durvalumab or tremelimumab monotherapy for patients with solid tumors: A systematic review and meta-analysis. [2022]The combination of durvalumab and tremelimumab results in clinical benefit, with a tolerable safety profile in patients with solid tumors.
Patient-reported outcomes with durvalumab, with or without tremelimumab, plus chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (POSEIDON). [2023]In the phase 3 POSEIDON study, first-line tremelimumab plus durvalumab and chemotherapy significantly improved overall survival and progression-free survival versus chemotherapy in metastatic non-small-cell lung cancer (NSCLC). We present patient-reported outcomes (PROs).
[Imiquimod treatment of lentigo maligna to dermoscopic and histologic clearance]. [2018]Imiquimod is an immune system-modifying drug that switches the immune system to a Th1 response, enabling it to defeat virus-infected and neoplastic cells. We report on a 94-year-old woman with a large lentigo maligna (LM) on her cheek whom we treated with imiquimod 5% cream. Dermoscopy was used to identify the most suspect areas of the lesion for biopsy and in follow-up. By week 19 the lesion was cleared, and no remnants of the lesion were seen by dermoscopy or histology. Published LM cases treated with imiquimod are reviewed.
Imiquimod as Local Immunotherapy in the Management of Premalignant Cutaneous Conditions and Skin Cancer. [2023]Cutaneous cancers are, by far, the most common malignant neoplasms of the human being. Due to the great array of clinical conditions, their worldwide increasing incidence and the steady ageing of the population, non-invasive treatments modalities that show a good clinical response, a proper benefit-risk ratio and cosmetic results are becoming increasingly important in the clinical setting. Imiquimod is a topically applied immunomodulator which is often used in the management of several premalignant and malignant cutaneous disorders. This article is a review of the current literature on its mechanism of action, pharmacokinetics, and therapeutical effects.
Successful treatment of persistent melanoma in situ with 5% imiquimod cream. [2018]Five percent imiquimod cream, a topically applied immune response modifier with potent antiviral and antitumor activity, has been reported to be effective in the management of lentigo maligna and cutaneous metastases from melanoma.
Imiquimod is a strong inhibitor of tumor cell-induced angiogenesis. [2018]Imiquimod, a potent immunomodulator, not having a direct antiproliferative activity, was found to be effective in genital and cutaneous premalignancies and malignancies. As tumor development depends on blood vessel supply, the inhibition of angiogenesis could be responsible for the antitumor activity.
[Pharma clinics. Medication of the month. Imiquimod (Aldara): an immunomodulator for the skin]. [2018]Imiquimod is the first drug of a new therapeutic class encompassing cutaneous immune response modifiers. This molecule induces the synthesis and release of macrophage-related cytokines. It boosts some local immune responses. These properties are used to treat cutaneous viral condylomas. Other prospective therapeutic goals are presently scrutinized.