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Checkpoint Inhibitor
Tremelimumab + Durvalumab for Sarcoma
Phase 2
Waitlist Available
Led By Neeta Somaiah, MBBS
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: >/= 18 years of age
Histologically or cytologically confirmed sarcoma falling into specified categories
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
Study Summary
This trial is testing if durvalumab and tremelimumab can help control sarcoma and is also studying the safety of the drug combination.
Who is the study for?
This trial is for adults with various types of sarcoma who have not responded to standard treatments. Participants must have a life expectancy of at least 6 months, measurable tumors, and good organ function. They should be able to perform daily activities with little or no assistance (ECOG status 0 or 1). Women capable of childbearing must use effective contraception.Check my eligibility
What is being tested?
The study tests the combination of two investigational drugs, durvalumab and tremelimumab, for their effectiveness in controlling sarcoma. The safety profile of this drug combo is also under evaluation. All participants will receive these drugs at MD Anderson Cancer Center.See study design
What are the potential side effects?
As durvalumab and tremelimumab are still being researched, potential side effects include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, digestive issues such as nausea or diarrhea, blood abnormalities leading to increased risk of infections or bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My cancer is a type of sarcoma confirmed by lab tests.
Select...
I am fully active or can carry out light work.
Select...
My sarcoma hasn't responded to standard treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Complete Response Rate
Overall Survival (OS)
Partial Response Rate Assessed by the Immune Response Evaluation Criteria in Solid Tumors (irRECIST)
+2 moreSide 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
6Treatment groups
Experimental Treatment
Group I: Vascular Tumors GroupExperimental Treatment2 Interventions
Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas.
Age group ≥12 and <18: Dosages of study drugs to be determined (TBD).
Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles.
Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses.
Group II: Undifferentiated Pleomorphic Sarcoma GroupExperimental Treatment2 Interventions
Age group ≥12 and <18: Dosages of study drugs to be determined (TBD).
Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles.
Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses.
Group III: Synovial Sarcoma GroupExperimental Treatment2 Interventions
Age group ≥12 and <18: Dosages of study drugs to be determined (TBD).
Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles.
Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses.
Group IV: Other Sarcomas GroupExperimental Treatment2 Interventions
Age group ≥12 and <18: Dosages of study drugs to be determined (TBD).
Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles.
Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses.
Group V: Osteosarcoma GroupExperimental Treatment2 Interventions
Age group ≥12 and <18: Dosages of study drugs to be determined (TBD).
Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles.
Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses.
Group VI: Adipocytic Tumors GroupExperimental Treatment2 Interventions
Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS.
Age group ≥12 and <18: Dosages of study drugs to be determined (TBD).
Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles.
Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3380
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,725 Total Patients Enrolled
55 Trials studying Sarcoma
18,197 Patients Enrolled for Sarcoma
MedImmune LLCIndustry Sponsor
347 Previous Clinical Trials
793,853 Total Patients Enrolled
1 Trials studying Sarcoma
58 Patients Enrolled for Sarcoma
Neeta Somaiah, MBBSPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any other cancer except certain non-dangerous types in the last 2 years.I have not received a live vaccine recently.I have not had major surgery recently.I don't have ongoing side effects from cancer treatment, except for minor ones.I have used immunosuppressive medication recently.I have had a primary immunodeficiency, organ transplant, or tuberculosis.I do not have any uncontrolled illnesses.I have had pneumonitis or lung disease in the past.I am 18 years old or older.My cancer is a type of sarcoma confirmed by lab tests.I agree to provide samples of my tumor for research.I am fully active or can carry out light work.You are expected to live for at least 6 more months.My cancer has spread to my brain or spinal cord and hasn't been treated.I have had an autoimmune disease in the last 2 years.I am not currently on any cancer treatments like chemotherapy or immunotherapy.My organs are functioning well.I have been treated with medications targeting PD1, PD-L1, or CTLA-4.I haven't taken any cancer treatment recently.My sarcoma hasn't responded to standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Osteosarcoma Group
- Group 2: Vascular Tumors Group
- Group 3: Undifferentiated Pleomorphic Sarcoma Group
- Group 4: Other Sarcomas Group
- Group 5: Adipocytic Tumors Group
- Group 6: Synovial Sarcoma Group
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.
Sarcoma Patient Testimony for trial: Trial Name: NCT02815995 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide a summary of the research conducted regarding Durvalumab's efficacy?
"At the time of writing, 340 research trials are investigating Durvalumab. Of those tests, 52 have progressed to Phase 3 and 13098 distinct locations are involved in these studies. Notably, there is a concentration of data collection centres based in Cordoba, Texas."
Answered by AI
In what contexts is Durvalumab commonly prescribed?
"Durvalumab is largely administered to patients with inoperable stage three non-small cell lung cancer. Additionally, it can be utilized for metastatic urothelial carcinoma and more advanced malignancies."
Answered by AI
Is enrollment still open for this trial?
"Clinicaltrials.gov indicates that this trial is not currently recruiting patients; the study was initially posted on August 16th 2016 and its last update occurred on October 31st 2022. Despite its status, there are many other clinical trials which are still open for enrollment at this time—with 783 studies in total."
Answered by AI
How many participants can this clinical trial accommodate?
"Unfortunately, the trial in question is not enrolling patients presently. It was first listed on August 16th 2016 and last modified October 31st 2022. However, there are 443 trials looking for sarcoma patients and 340 medical studies recruiting Durvalumab participants currently."
Answered by AI
To what extent can Durvalumab be detrimental to the health of those using it?
"As this is a Phase 2 trial, with prior evidence of safety and none in regards to efficacy, Durvalumab received an assessment score of two."
Answered by AI
Has this experiment been undertaken before?
"Since its initial clinical trial in 2007, Durvalumab has been tested across 58 nations and 1327 cities. So far, 340 active investigations have taken place with 123 studies having reached Phase 2 Drug Approvals. The first experiment was conducted by AstraZeneca on 37 patients."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I have had two different chemotherapy treatments and there are no other promising treatments that my oncologist could recommend. I would like to help find newer, more effective treatments for Angiosarcoma.
PatientReceived 1 prior treatment
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