← Back to Search

Anti-metabolites

Durvalumab + Chemotherapy for Cancer

Phase 2
Recruiting
Led By A P Chen
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor amenable to biopsy and willingness to undergo a tumor biopsy
Flash frozen tissue collected within 3 months prior to registration and no investigational or targeted treatment since that time
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months after the last dose of study drug
Awards & highlights

Study Summary

This trial is studying the side effects of durvalumab when given with chemotherapy to treat patients with advanced solid tumors.

Who is the study for?
This trial is for adults with advanced solid tumors that have spread and are not responding to standard treatments. Participants must be willing to undergo a biopsy, have an ECOG performance status of 0-2 (able to perform daily activities), adequate organ function, no serious autoimmune or inflammatory disorders, and not pregnant or breastfeeding. They should agree to use effective contraception and cannot have had certain severe reactions to similar drugs.Check my eligibility
What is being tested?
The DURVA+ study is testing the effectiveness of Durvalumab combined with various chemotherapy drugs like gemcitabine hydrochloride, pegylated liposomal doxorubicin hydrochloride, capecitabine, carboplatin, paclitaxel, and nab-paclitaxel in treating patients whose cancer has spread significantly. The goal is to see if this combination helps the immune system better attack cancer cells.See study design
What are the potential side effects?
Possible side effects include typical chemotherapy-related issues such as nausea, fatigue, hair loss; Durvalumab may cause immune-related problems like inflammation in organs or skin rashes. Each patient's experience can vary widely based on their individual health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am willing to have a biopsy of my tumor.
Select...
My tissue sample was collected and frozen within the last 3 months, and I haven't received any experimental treatments since.
Select...
I am able to get out of my bed or chair and move around.
Select...
My body weight is more than 30 kg.
Select...
I have a tumor that can be measured with a scan.
Select...
I am on treatment for bone metastases or high calcium levels.
Select...
I agree not to donate blood during the study and for 3 months after.
Select...
My kidneys are functioning well enough, based on a specific test.
Select...
My cancer has spread or grown after treatment, or there's no treatment proven to help.
Select...
I have a tumor that can be measured and is at least as big as specified.
Select...
My cancer is advanced, cannot be removed by surgery, and has worsened after treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am willing to have a biopsy and my tumor can be biopsied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 3 months after the last dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 3 months after the last dose of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Other outcome measures
Cell-free deoxyribonucleic acid (cfDNA)
Immune complex
Immune status of the tumor and overall tumor mutational load
+1 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
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

7Treatment groups
Experimental Treatment
Active Control
Group I: Arm VII (nab-paclitaxel, durvalumab)Experimental Treatment5 Interventions
Patients receive nab-paclitaxel IV over 30 minutes on day 1 and durvalumab IV over 60 minutes on day 8 of cycle 1, days 8 and 15 of cycle 2, day 8 of cycles 3, and day 1 of subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT throughout the trial. Patients also undergo tissue biopsy and blood sample collection during screening and on the trial.
Group II: Arm VI (paclitaxel, durvalumab)Experimental Treatment5 Interventions
Patients receive paclitaxel IV over 60 minutes on day 1 and durvalumab IV over 60 minutes on day 8 of cycle 1, days 8 and 15 of cycle 2, day 8 of cycles 3, and day 1 of subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT throughout the trial. Patients also undergo tissue biopsy and blood sample collection during screening and on the trial.
Group III: Arm V (carboplatin, durvalumab)Experimental Treatment5 Interventions
Patients receive carboplatin IV over 30-60 minutes on day 1 and durvalumab IV over 60 minutes on day 8 of cycle 1, days 8 and 15 of cycle 2, day 8 of cycles 3, and day 1 of subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT throughout the trial. Patients also undergo tissue biopsy and blood sample collection during screening and on the trial.
Group IV: Arm IV (capecitabine, durvalumab)Experimental Treatment5 Interventions
Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14, and durvalumab IV over 60 minutes on days 8 of cycle 1, day 8 and 15 of cycle 2, day 8 of cycles 3, and day 1 of subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT throughout the trial. Patients also undergo tissue biopsy and blood sample collection during screening and on the trial.
Group V: Arm III (pegylated liposomal doxorubicin, durvalumab)Experimental Treatment6 Interventions
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and durvalumab IV over 60 minutes on days 8 and 22 of cycles 1 and 2 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening. Patients undergo CT throughout the trial. Patients also undergo tissue biopsy and blood sample collection during screening and on the trial.
Group VI: Arm II (gemcitabine hydrochloride, durvalumab)Experimental Treatment5 Interventions
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and durvalumab IV over 60 minutes on days 8 and 22 of cycles 1 and 2 and day 8 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who discontinue gemcitabine hydrochloride continue receiving durvalumab alone as in Arm I. Patients undergo CT throughout the trial. Patients also undergo tissue biopsy and blood sample collection during screening and on the trial.
Group VII: Arm I (durvalumab)Active Control4 Interventions
Patients receive durvalumab IV over 60 minutes on days 1 and 15 of cycles 1 and 2 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT throughout the trial. Patients also undergo tissue biopsy and blood sample collection during screening and on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Paclitaxel
2011
Completed Phase 4
~5380
Echocardiography
2013
Completed Phase 4
~11670
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Pegylated Liposomal Doxorubicin Hydrochloride
2001
Completed Phase 3
~4520
Carboplatin
2014
Completed Phase 3
~6670
Capecitabine
2013
Completed Phase 3
~3420
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Nab-paclitaxel
2014
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,739 Total Patients Enrolled
A P ChenPrincipal InvestigatorNational Cancer Institute LAO
7 Previous Clinical Trials
475 Total Patients Enrolled

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03907475 — Phase 2
Cancer Research Study Groups: Arm I (durvalumab), Arm VII (nab-paclitaxel, durvalumab), Arm VI (paclitaxel, durvalumab), Arm V (carboplatin, durvalumab), Arm II (gemcitabine hydrochloride, durvalumab), Arm III (pegylated liposomal doxorubicin, durvalumab), Arm IV (capecitabine, durvalumab)
Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT03907475 — Phase 2
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03907475 — Phase 2

Frequently Asked Questions

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

Have similar studies been conducted in the past?

"Durvalumab has a long research history, with the first clinical trial taking place in 1997. Sponsored by Alfacell, this initial study had 300 participants. After successful completion, Durvalumab received Phase 3 approval and is now being trialed in 2321 live trials across 4365 cities and 90 countries."

Answered by AI

Has the FDA given Durvalumab their stamp of approval?

"Durvalumab has not been proven effective yet in clinical trials, however, there is some data supporting its safety which gives it a score of 2."

Answered by AI

Are there any vacancies in this clinical trial for new participants?

"The most recent information available indicates that this trial is actively recruiting patients. The original posting was on June 25th, 2019, with the last update occurring on June 28th, 2022."

Answered by AI

How many guinea pigs are needed for this test?

"The trial is recruiting for 115 patients across 1 sites."

Answered by AI

Are there any other ongoing studies that are testing Durvalumab?

"There are a total of 2321 ongoing studies investigating Durvalumab. Out of these, 635 are large-scale Phase 3 trials. The majority of these research projects focusing on Durvalumab are located in Guangzhou, Guangdong; however, there are 104963 clinical trial sites worldwide where patients can receive this medication."

Answered by AI

For what purpose is Durvalumab commonly employed?

"Durvalumab is not only approved for the treatment of typhus, but also kaposi's sarcoma aids related, helicobacter pylori infection, and endometritis."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, (DURVA+ Study)
2019. "Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, (DURVA+ Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03907475.
~2 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top