Your session is about to expire
← Back to Search
PI3K Inhibitor
Duvelisib + Nivolumab for Melanoma
Phase 1 & 2
Recruiting
Led By John Kirkwood, MD
Research Sponsored by John Kirkwood
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤ 2 or Karnofsky ≥ 60%
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (prior to treatment), at 12 weeks after start of treatment; up to 2 years (cohort)
Awards & highlights
Study Summary
This trial is testing a new combination therapy to treat advanced melanoma that has progressed after anti-PD1 therapy. The new therapy consists of two drugs, given orally and intravenously. The goal is to find the recommended dose of the oral drug and to see if the combination therapy can help the patient's disease from progressing.
Who is the study for?
Adults (18+) with advanced unresectable melanoma that worsened after anti-PD1 therapy can join. They must have measurable disease, be willing to use effective birth control, and have normal organ/bone marrow function. Excluded are those with significant infections, recent treatments, allergies to trial drugs, CNS metastases unless stable, autoimmune diseases except mild ones like type I diabetes or skin disorders not needing systemic treatment.Check my eligibility
What is being tested?
The study tests a combination of oral duvelisib and intravenous nivolumab in patients with advanced melanoma who didn't respond to previous anti-PD1 therapy. The Phase I part determines the safe dose for Phase II where it's given up to one year or until disease progression or unacceptable side effects occur.See study design
What are the potential side effects?
Potential side effects include immune-related issues such as inflammation in organs; reactions at the infusion site; fatigue; digestive problems; blood disorders; increased risk of infection; and possible harm to an unborn baby.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years old or older.
Select...
I have a tumor that can be measured and is at least 10mm in size.
Select...
I am a woman capable of becoming pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (prior to treatment), at 12 weeks after start of treatment; up to 2 years (cohort)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (prior to treatment), at 12 weeks after start of treatment; up to 2 years (cohort)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in CD +8 TIL frequency
Nivolumab
Overall Response Rate (ORR)
Secondary outcome measures
Adverse events graded by CTCAE v5.0
Clinical Benefit
Duration of Response
+3 moreOther outcome measures
Immune Cell Function
Mechanism of anti-PD1 Resistance
Tumor Microenvironment (TME)
Side effects data
From 2021 Phase 3 trial • 319 Patients • NCT0200452250%
Diarrhoea
34%
Neutropenia
29%
Pyrexia
25%
Anaemia
24%
Nausea
23%
Cough
17%
Thrombocytopenia
17%
Constipation
16%
Fatigue
16%
Pneumonia
15%
Vomiting
15%
Decreased appetite
14%
Upper respiratory tract infection
13%
Colitis
13%
Asthenia
13%
Weight decreased
13%
Bronchitis
11%
Abdominal pain
11%
Rash
10%
Hypokalaemia
10%
Oedema peripheral
9%
Dyspnoea
9%
Aspartate aminotransferase increased
8%
Alanine aminotransferase increased
8%
Back pain
8%
Dizziness
8%
Headache
8%
Hypertension
8%
Nasopharyngitis
7%
Arthralgia
7%
Pruritus
7%
Hyperkalaemia
7%
Respiratory tract infection
6%
Rash maculo-papular
6%
Febrile neutropenia
6%
Rhinorrhoea
6%
Dyspepsia
6%
Pain in extremity
6%
Abdominal pain upper
5%
Dehydration
5%
Insomnia
5%
Productive cough
5%
Dry mouth
4%
Muscle spasms
4%
Paraesthesia
4%
Pneumonitis
3%
Toxic skin eruption
3%
Renal failure acute
3%
Hypotension
3%
General physical health deterioration
3%
Gastroenteritis
2%
Gastritis
2%
Pneumonia pseudomonas aeruginosa
2%
Pancytopenia
2%
Cardiac failure
2%
Sepsis
2%
Pneumocystis jirovecii pneumonia
2%
Pneumonia pneumococcal
2%
Pulmonary embolism
1%
Enterocolitis
1%
Pneumonia staphylococcal
1%
Urinary tract infection
1%
Pneumonia aspiration
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Interstitial lung disease
1%
Respiratory failure
1%
Mental impairment
1%
Pleural haemorrhage
1%
Pneumonia klebsiella
1%
Streptococcal sepsis
1%
Rash erythematous
1%
Proctitis
1%
Fungal oesophagitis
1%
Accidental overdose
1%
Intestinal adenocarcinoma
1%
Deep vein thrombosis
1%
Haemolytic anaemia
1%
Atrial fibrillation
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Pericarditis
1%
Death
1%
Mucosal inflammation
1%
Multi-organ failure
1%
Sudden death
1%
Transitional cell carcinoma
1%
Bronchiolitis
1%
Bronchitis viral
1%
Bronchopneumonia
1%
Cytomegalovirus colitis
1%
Pneumonia escherichia
1%
Pneumonia mycoplasmal
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Subdural haematoma
1%
Lipase increased
1%
Nephrolithiasis
1%
Renal colic
1%
Renal failure
1%
Renal failure chronic
1%
Lung disorder
1%
Ventricular tachycardia
1%
Colitis ischaemic
1%
Enteritis
1%
Pancreatitis acute
1%
Ileal ulcer
1%
Aspergillus infection
1%
Bronchopulmonary aspergillosis
1%
Campylobacter gastroenteritis
1%
Clostridium difficile colitis
1%
Fungal infection
1%
Influenza
1%
Pseudomonal sepsis
1%
Lower respiratory tract infection
1%
Pneumonia bacterial
1%
Enterococcal infection
1%
Enterococcal sepsis
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Gastroenteritis viral
1%
Haemophilus infection
1%
Infection
1%
Infusion site cellulitis
1%
Lobar pneumonia
1%
Lower respiratory tract infection viral
1%
Lung infection
1%
Pneumonia respiratory syncytial viral
1%
Pneumonia streptococcal
1%
Pseudomonas bronchitis
1%
Wound infection staphylococcal
1%
Cervical vertebral fracture
1%
Femur fracture
1%
Traumatic haematoma
1%
Malnutrition
1%
Hyponatraemia
1%
Tumour lysis syndrome
1%
Arthritis
1%
Bone pain
1%
Malignant melanoma
1%
Brain stem haemorrhage
1%
Dementia
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Dermatitis exfoliative
1%
Thrombosis
1%
Infusion related reaction
1%
Neuroendocrine tumour
1%
Pleural effusion
1%
Mallory-Weiss syndrome
1%
Diverticulitis
1%
Pyelonephritis
1%
Haemorrhagic stroke
1%
Dermatitis allergic
1%
Respiratory tract infection bacterial
1%
Splenic rupture
1%
Neuroendocrine carcinoma of the skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duvelisib
Ofatumumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Duvelisib plus NivolumabExperimental Treatment2 Interventions
Phase 1: Duvelisib will be taken orally in doses from 15mg once a day, 25mg once a day or 25mg twice a day, 12 hours a part, to determine the recommended dose for the Phase II study when combined with nivolumab.
Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks if deemed appropriate by the study doctor.
Phase II: The Recommended Phase II dosage of duvelisib administered will not be determined until Phase I is completed.
Nivolumab, 480mg, IV, every 4 weeks, for up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Duvelisib
2016
Completed Phase 3
~760
Find a Location
Who is running the clinical trial?
John KirkwoodLead Sponsor
4 Previous Clinical Trials
82 Total Patients Enrolled
4 Trials studying Melanoma
82 Patients Enrolled for Melanoma
Secura Bio, Inc.Industry Sponsor
8 Previous Clinical Trials
206 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,958 Total Patients Enrolled
177 Trials studying Melanoma
57,501 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I have had T-vec therapy, but not more than three patients like me can join the Phase II study.I had a severe immune reaction in my gut but tolerated treatment after anti-CTLA-4 therapy.I had severe side effects from previous immune therapy, but they are now under control.I cannot or will not take preventive medication for certain infections.I have another cancer besides the one being studied, but it's either not progressing or doesn't need active treatment, except for certain skin cancers or treated cervical cancer.I am 18 years old or older.My organs and bone marrow are functioning normally.I haven't had cancer treatment in the last 4 weeks and have recovered from any side effects.I have had surgery or chronic issues affecting how my body absorbs drugs.I am not pregnant and will use effective birth control during and after the study.My melanoma is advanced and didn't respond to specific immune treatments.I do not have chronic liver issues, veno-occlusive disease, nor do I abuse alcohol or use illicit drugs, except for marijuana.I do not have serious heart problems.I have an autoimmune disease but it's mild or under control with minimal treatment.I am willing and able to follow the study's requirements.I cannot or do not want to have blood drawn from my veins.I have a tumor that can be measured and is at least 10mm in size.I am not allergic to duvelisib or its ingredients.I do not have any significant or uncontrolled infections.I haven't taken strong CYP3A affecting drugs or certain foods in the last 2 weeks.I do not have brain metastases, or if I do, they meet specific criteria.I do not have uveal or mucosal melanoma.I do not have any severe lung conditions.You are being held against your will for treatment of a mental or physical illness.I have had severe lung inflammation or liver enzyme issues.I have been treated with PI3K inhibitors before.I have a BRAF mutation and have tried or considered BRAF and MEK inhibitors before this trial.I am a woman capable of becoming pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Duvelisib plus Nivolumab
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.
How many participants are being monitored in this investigation?
"Affirmative. The information on clinicaltrials.gov supports that this medical examination is currently open for enrollment, which commenced on July 21st 2021 and has been updated as recently as April 19th 2022. 42 participants are required from a single health facility."
Answered by AI
What diseases is Duvelisib commonly employed to alleviate?
"Typically prescribed to address aplastic anemia, duvelisib is also capable of treating metastatic hepatocellular carcinoma, classical hodgkin's lymphoma and metastatic ureter urothelial carcinoma."
Answered by AI
Are there still opportunities for individuals to join this clinical experiment?
"Affirmative, the clinicaltrials.gov website confirms that this trial is enlisting participants. The study was published on July 21st 2021 and has been updated as recently April 19th 2022. It requires a total of 42 patients to be recruited from 1 medical centre."
Answered by AI
What goals is this research endeavor seeking to accomplish?
"This clinical trial assesses the Overall Response Rate (ORR) over a 56-day period. Secondary metrics of success include measuring patients' Overall Survival, Progression-Free Survival, and Percentage of Adverse Events related to treatment as per CTCAE v5.0 criteria within 56 days from initiation."
Answered by AI
Is this research an innovative endeavor?
"Currently, 772 clinical trials related to Duvelisib are underway across 2439 cities and 50 nations. This research originates from a 2011 trial initiated by Pfizer which involved 39 volunteers successfully concluding its Phase 2 approval stage. In the decade since then, an additional 344 experiments have been conducted."
Answered by AI
To what extent has Duvelisib been the focus of scientific research?
"Currently, 772 clinical trials related to Duvelisib are ongoing with 86 of them in their final phase. Furthermore, there is a vast network of 41052 medical facilities testing the drug worldwide; many of which situated around Basel in Switzerland."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger