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PD-L1 Inhibitor
Guadecitabine + Durvalumab for Kidney Cancer
Phase 1 & 2
Waitlist Available
Led By Ajjai Alva, M.D.
Research Sponsored by Ajjai Alva, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combining two drugs, given to patients who have had one or no previous treatments. The study will last up to 52 weeks.
Eligible Conditions
- Clear Cell Renal Cell Carcinoma
- Kidney Cancer
- Renal Cell Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate
Phase Ib: Dose limiting toxicities will be assessed to determine if the trial is stopped before the Phase II portion.
Secondary outcome measures
Phase II: Assess Adverse Events
Phase II: Clinical benefit rate (CBR)
Phase II: Complete response (CR) proportion
+4 moreSide effects data
From 2020 Phase 3 trial • 417 Patients • NCT0290735934%
Neutropenia
31%
Thrombocytopenia
30%
Febrile Neutropenia
27%
Pneumonia
23%
Anaemia
23%
Constipation
22%
Diarrhoea
22%
Fatigue
22%
Pyrexia
20%
Asthenia
18%
Decreased Appetite
17%
Injection Site Reaction
17%
Hypokalaemia
16%
Epistaxis
16%
Nausea
16%
Oedema Peripheral
14%
Stomatitis
14%
Cough
13%
Dizziness
13%
Headache
12%
Back Pain
12%
Leukopenia
12%
Dyspnoea
11%
Insomnia
11%
Vomiting
10%
Rash
10%
Sepsis
10%
Abdominal Pain
9%
Petechiae
9%
Contusion
8%
Weight Decreased
8%
Cellulitis
7%
Arthralgia
7%
Pruritus
6%
Fall
6%
Musculoskeletal Pain
6%
Septic Shock
6%
Upper Respiratory Tract Infection
6%
Transfusion Reaction
6%
Pain In Extremity
6%
Haematoma
6%
Haemorrhoids
6%
Hypotension
5%
Urinary Tract Infection
5%
Blood Creatinine Increased
5%
Hypomagnesaemia
5%
Oropharyngeal Pain
5%
Erythema
5%
Oedema
5%
Alanine Aminotransferase Increased
4%
Nasopharyngitis
4%
Aspartate Aminotransferase Increased
4%
Bacteraemia
2%
Atrial Fibrillation
1%
Cardiac Failure Congestive
1%
Cholangitis
1%
Pulmonary Embolism
1%
Subcutaneous Abscess
1%
Acute Myocardial Infarction
1%
General Physical Health Deterioration
1%
Tumour Lysis Syndrome
1%
Angina Pectoris
1%
Colitis
1%
Anal Abscess
1%
Device Related Infection
1%
Cardiac Failure
1%
Gastrointestinal Haemorrhage
1%
Lower Gastrointestinal Haemorrhage
1%
Multiple Organ Dysfunction Syndrome
1%
Bronchopulmonary Aspergillosis
1%
Infection
1%
Urosepsis
1%
Bronchitis
1%
Cellulitis Orbital
1%
Chronic Sinusitis
1%
Corynebacterium Infection
1%
Pseudomonal Bacteraemia
1%
Sinusitis
1%
Staphylococcal Bacteraemia
1%
Subarachnoid Haemorrhage
1%
Haematuria
1%
Respiratory Tract Infection
1%
Haemorrhage Intracranial
1%
Prostatitis
1%
Febrile Bone Marrow Aplasia
1%
Leukocytosis
1%
Leukostasis Syndrome
1%
Pancytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guadecitabine
Treatment Choice
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
This is a non-randomized, single arm, open label Phase Ib/II study.
Phase Ib:
Days 1-5
Guadecitabine:
Dose 0: 60 mg/m^2
Dose -1: 45 mg/m^2
Phase II:
Days 1-5 Guadecitabine (at Ph II dose)
Day 8 Durvalumab (1500 mg IV) Day 8 Durvalumab (1500 mg IV)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Guadecitabine
2014
Completed Phase 3
~570
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,286 Previous Clinical Trials
288,619,993 Total Patients Enrolled
Big Ten Cancer Research ConsortiumOTHER
10 Previous Clinical Trials
417 Total Patients Enrolled
Ajjai Alva, MDLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are still experiencing moderate or severe side effects from previous cancer treatments, except for hair loss, skin discoloration, and specific lab test results mentioned in the inclusion criteria.You have received an organ transplant and are taking medicines to lower your immune system.You weigh more than 30 kilograms.You have an ongoing infection that needs to be treated with medication throughout your body.You have taken medication that weakens your immune system in the past 28 days before starting durvalumab.You have a current infection like tuberculosis, hepatitis B, hepatitis C, or HIV.Women who could become pregnant must have a negative pregnancy test within 28 days before joining the study.You weigh less than 30 kilograms.You have a history of lung disease that needed treatment with steroids.You have cancer that has spread to your brain or is pressing on your spinal cord.You had another type of cancer in the past, but it was treated and there is a low chance of it coming back. Skin cancers that were treated successfully are okay.You have had a documented autoimmune or inflammatory disorder in the past 3 years.You have a serious illness that is not under control, such as an ongoing infection, heart problems, or lung disease.You have a history of cancer spreading to the tissues surrounding the brain and spinal cord.You have a known allergic reaction to the study drugs or similar types of medications.Your heart's electrical activity is measured and if the result is higher than 470 milliseconds, you may not be able to participate in the study.You have been diagnosed with clear cell renal cell carcinoma and have evidence of the cancer spreading to other parts of the body.You need to have a tumor that is at least 10 millimeters in size and can be accurately measured by CT or MRI. If it's in a lymph node, it needs to be at least 15 millimeters.For cohort 1, you can have had only one prior treatment for your advanced cancer, but not with specific types of drugs. You cannot have had a specific type of immunotherapy called anti-PD-1/PD-L1/CTLA4 therapy.You may have had up to 2 previous treatments, including 1 anti-PD-1/PD-L1 therapy, but it did not work for you. You may have also received anti-CTLA4 therapy before.
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.
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