Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Durvalumab + Tremelimumab for Rare Cancers
Phase 2
Recruiting
Led By William J Edenfield, MD
Research Sponsored by Prisma Health-Upstate
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate normal organ and marrow function including: hemoglobin > 9.0 g/dl; ANC > 1500 per mm3; platelet count > 100,000 per mm3; bilirubin < 1.5 x ULN; ALT/AST < 2.5 x ULN unless liver metastases present in which case must be < 5 x ULN; creatinine clearance > 40 ml/min by Cockcroft-Gault or 24 hour urine collection
ECOG performance status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will test how well a combination of two immunotherapy drugs work in treating advanced rare solid tumors.
Who is the study for?
This trial is for adults with rare advanced solid tumors who've had no luck with standard treatments or can't receive them. They should be relatively active (ECOG 0-2), able to undergo a tumor biopsy, and have their major organs functioning well. People who've previously used durvalumab, tremelimumab, or similar drugs; those with untreated brain metastases; recent steroid users; and patients with certain autoimmune diseases or other specific cancers under study elsewhere are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Durvalumab and Tremelimumab in people with rare types of cancer that have spread. It's an open-label study where everyone knows what treatment they're getting, aiming to see how effective this drug combo is at fighting these cancers while also monitoring safety and side effects.See study design
What are the potential side effects?
Durvalumab and Tremelimumab might cause immune-related reactions affecting various organs, fatigue, infusion reactions like fever or chills during administration, potential blood abnormalities such as low platelet counts which could increase bleeding risk, liver function changes indicated by enzyme levels in the blood tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood, liver, and kidney functions are within normal ranges required for the trial.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have a rare advanced solid tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Antitumor Activity
Incidence of Treatment-Emergent and Non Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Expression of programmed cell death protein 1 (PD-1)
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
Durvalumab, 1500 mg Q4W (equivalent to 20 mg/kg Q4W) intravenously for 13 doses and Tremelimumab 300mg intravenously as a single dose on cycle 1 day 1 only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Find a Location
Who is running the clinical trial?
Prisma Health-UpstateLead Sponsor
83 Previous Clinical Trials
42,878 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,281 Previous Clinical Trials
288,616,277 Total Patients Enrolled
MedImmune LLCIndustry Sponsor
347 Previous Clinical Trials
793,759 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 3 more months.My blood, liver, and kidney functions are within normal ranges required for the trial.I haven't had chemotherapy in the last 4 weeks.Standard treatments have not worked for me or I was not eligible for them.I can take care of myself and am up and about more than half of my waking hours.My cancer has spread to my brain and has not been treated.I have had an autoimmune disease in the last 2 years.I have previously been treated with a checkpoint inhibitor.I have a rare advanced solid tumor.I am willing to undergo a biopsy or have recent biopsy samples.I have been treated with durvalumab or tremelimumab before.My cancer type is being studied in other research.My psoriasis is not under control.I haven't taken steroids recently, except for low-dose or inhaled ones.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Has Durvalumab been the focus of any other research efforts?
"Currently, the world's 340 active studies on durvalumab are spread across 13083 different sites with 52 of these trials in Phase 3. Specifically, several research projects within Cordoba, Texas have begun to trial this drug."
Answered by AI
How many participants has this trial enrolled so far?
"Indeed, the clinicaltrials.gov portal states that this trial has recently resumed its search for patients to partake in their research. The data was initially posted on December 1st 2016 and updated most recently on April 25th 2022, with 100 participants sought at a single medical centre."
Answered by AI
Are there any openings remaining for this trial of medical treatment?
"Clinicaltrials.gov states that this experiment is still accepting participants, having been posted on the 1st of December 2016 and modified as recently as April 25th 2022."
Answered by AI
Does this medical experiment represent a pioneering endeavor?
"Global research into Durvalumab has been ongoing since 2007 when AstraZeneca launched a 37-patient Phase 2 study. More recently, 340 such trials have occurred in 58 countries and 1327 cities. 123 of these investigations have concluded thus far."
Answered by AI
For what purposes is Durvalumab most regularly utilized?
"Durvalumab is routinely prescribed to treat inoperable stage III non-small cell lung cancer and has extended applications for metastatic ureter urothelial carcinoma, as well as advanced directives."
Answered by AI
What potential risks come with utilizing Durvalumab?
"Although there is supportive data suggesting its safety, the absence of any clinical evidence indicating efficacy leads Power to rate Durvalumab's safety as a 2 on their scale."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger