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Checkpoint Inhibitor

Durvalumab + Tremelimumab for Solid Tumors

Phase 2
Waitlist Available
Led By John Villano, MD
Research Sponsored by John L. Villano, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years at time of study entry
Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy. Not engaging in sexual activity is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male patients should refrain from sperm donation throughout this period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years (baseline to follow-up)
Awards & highlights

Study Summary

This trial will see if a new cancer treatment helps people with relapsed/refractory solid tumors who have evidence of somatic hypermutation.

Who is the study for?
Adults over 18 with relapsed/refractory solid tumors and a high or moderate tumor mutational burden, who haven't had prior anti-PD-1/PD-L1 or anti-CTLA-4 therapy. Participants must have good organ function, not be pregnant or breastfeeding, use effective contraception, and have no history of certain autoimmune diseases or uncontrolled illnesses.Check my eligibility
What is being tested?
The trial is testing the combination of Durvalumab and Tremelimumab to see if they improve progression-free survival in patients with solid tumors that show somatic hypermutation. It's for those whose cancer has returned after treatment.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions affecting different organs, infusion-related symptoms like fever or chills, fatigue, gastrointestinal issues such as diarrhea or nausea, skin rash, hormonal gland problems (like thyroid dysfunction), and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I am a man who will use approved birth control methods if I have sex, or I won't have sex.
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My kidney function, measured by creatinine clearance, is above 40 mL/min.
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I can do some of my daily activities and my doctor thinks I have more than 3 months to live.
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My tumor is not microsatellite instability-high (MSI-H) or mismatch repair deficient.
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My tumor has a high or moderate number of mutations and I haven't had specific immunotherapy.
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I weigh more than 30 kilograms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years (baseline to follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years (baseline to follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time-to-progression ratio (TTP)
Secondary outcome measures
Progression-free survival

Side effects data

From 2023 Phase 2 trial • 72 Patients • NCT02937818
52%
Anaemia
14%
Pyrexia
14%
Nausea
14%
Vomiting
10%
Musculoskeletal pain
10%
Platelet count decreased
10%
Dyspnoea
5%
Insomnia
5%
Constipation
5%
Dysphonia
5%
Thrombocytopenia
5%
Asthenia
5%
Cough
5%
Decreased appetite
5%
Abdominal pain
5%
Depressed mood
5%
Pneumonia
5%
Urinary tract infection
5%
Fatigue
5%
Diarrhoea
5%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm C: Ceralasertib (AZD6738) + Olaparib
Arm B: Adavosertib + Carboplatin
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)
Arm A: Durvalumab + Tremelimumab (Original Cohort)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with moderate to high tumor mutational burdenExperimental Treatment1 Intervention
Patients with recurrent or refractory disease in solid tumors naïve to anti-PD-1/PD-L1 or anti-CTLA-4 immunotherapy and have moderate to high tumor mutational burden (TMB)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

John L. Villano, MD, PhDLead Sponsor
2 Previous Clinical Trials
79 Total Patients Enrolled
John Villano, MDPrincipal InvestigatorUniversity of Kentucky

Frequently Asked Questions

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

Could you compare and contrast this research with other similar investigations?

"As of now, there are a combined 345 ongoing trials researching Durvalumab and Tremelimumab with 51 of them in Phase 3. While a majority of the studies for Durvalumab and Tremelimumab are based Cordoba, Texas, there are 13051 locations running these types of studies."

Answered by AI

Does this research stand alone, or has it been done before?

"Since 2007, medical researchers have been studying Durvalumab and Tremelimumab. After an initial clinical trial involving 37 people in 2007 that was sponsored by AstraZeneca, the drug received Phase 2 approval. In total, there are currently 345 active trials being conducted for Durvalumab and Tremelimumab across 58 countries and 1325 cities."

Answered by AI

What have been the most serious adverse effects of Durvalumab and Tremelimumab?

"Durvalumab and Tremelimumab's safety is unknown because this is a Phase 2 trial. There is data supporting its safety, but none indicating whether or not it actually works."

Answered by AI

What symptoms have been shown to respond well to Durvalumab and Tremelimumab?

"Durvalumab and Tremelimumab is an effective treatment for unresectable stage iii non-small cell lung cancer, as well as other conditions like previously untreated, metastatic ureter urothelial carcinoma."

Answered by AI

Are new participants being accepted into this research project?

"That is accurate. The clinical trial was originally posted on 6/8/2019 and has been actively recruiting since then. Currently, the trial is looking for 48 patients from 1 location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Durvalumab and Tremelimumab Combination in Somatically Hypermutated Recurrent Solid Tumors
John L. Villano, MD, PhD 2019. "Durvalumab and Tremelimumab Combination in Somatically Hypermutated Recurrent Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03911557.
~3 spots leftby Jun 2025
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