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Checkpoint Inhibitor
Pixatimod + Nivolumab for Cancer
Phase 2
Waitlist Available
Led By Diwakar Davar, MD
Research Sponsored by Diwakar Davar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Male/female participants who are at least 18 years of age on the day of signing informed consent with advanced/metastatic cutaneous melanoma, NSCLC or MSS mCRC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing the effectiveness of two drugs, nivolumab and pixatimod, either alone or in combination with a third drug, cyclophosphamide. The trial will enroll patients with three different types of cancer: colon cancer, melanoma, and lung cancer.
Who is the study for?
Adults with advanced melanoma, NSCLC, or MSS mCRC that have not responded to PD-1 treatments can join. They must be healthy enough for the trial (ECOG 0-1), not pregnant or breastfeeding, willing to use birth control, and have no recent other treatments or serious health issues like heart disease or active infections.Check my eligibility
What is being tested?
The trial is testing how well patients respond to combinations of drugs: Pixatimod with Nivolumab for melanoma and NSCLC; plus low-dose Cyclophosphamide for MSS mCRC. Patients are grouped based on their cancer type and receive specific drug combos accordingly.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, digestive problems such as diarrhea, blood cell changes increasing infection risk. Each patient may experience different side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am 18 or older with advanced skin melanoma, lung cancer, or colorectal cancer.
Select...
I have given a fresh biopsy sample from a tumor that hasn't been treated with radiation.
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I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 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 (ORR) - (Cohort 1)
Objective Response Rate (ORR) - (Cohorts 2 & 3)
Secondary outcome measures
1-year Overall Survival (OS)
1-year Progression-free Survival (PFS)
2-year Overall Survival (OS)
+7 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pixatimod (PG545) + Nivolumab + cyclophosphamideExperimental Treatment3 Interventions
Pixatimod : 25 mg IV, weekly
Nivolumab: 480 mg IV, Q4 weeks
cyclophosphamide: 50 mg PO twice daily (Day 1-Day 7; Day 15-Day 21) with a 7-day drug free interval (Day 8-Day 14 and Day 22-Day 28)
Cohort 2 (PD-1 R/R melanoma) and Cohort 3 (PD-1 R/R NSCLC)
Group II: Pixatimod (PG545) + NivolumabExperimental Treatment2 Interventions
Pixatimod : 25 mg IV, weekly
Nivolumab: 480 mg IV, Q4 weeks
Cohort 1 (MSS CRC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Aculeus TherapeuticsUNKNOWN
Diwakar DavarLead Sponsor
10 Previous Clinical Trials
397 Total Patients Enrolled
Zucero Pty LtdIndustry Sponsor
2 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active hepatitis B or C infection.I have a lung condition not caused by an infection.I don't have any health issues that could affect the trial's results.I agree to use birth control and not donate sperm for 120 days after my last treatment dose.I am fully active or can carry out light work.I have not used heparin in the last 2 weeks.I do not have any severe illnesses or conditions that would stop me from following the study's requirements.I have been diagnosed with HIV.I have an immune system disorder or have been on steroids recently.I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.I am a woman who can have children and have a negative pregnancy test taken within the last 3 days.I have not received any live vaccines in the last 30 days.My colorectal cancer is MSS and meets specific genetic and treatment history criteria.I am 18 or older with advanced skin melanoma, lung cancer, or colorectal cancer.I am not pregnant or breastfeeding and follow specific birth control advice.My organ functions are within normal ranges according to recent tests.My melanoma has not responded to previous PD-1 treatments.My NSCLC is resistant to PD-1 inhibitors and meets specific criteria for treatment history and disease progression.You must have a specific amount of disease that can be measured using a standard method.I have given a fresh biopsy sample from a tumor that hasn't been treated with radiation.I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.I agree to use birth control during and for 4 months after the study.I have a history of serious heart problems.I have another cancer that is getting worse or needs treatment.My cancer has spread to my brain or its coverings.I take more than 10 mg of prednisone daily for my condition.I am currently on medication for an infection.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Pixatimod (PG545) + Nivolumab + cyclophosphamide
- Group 2: Pixatimod (PG545) + Nivolumab
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Nivolumab been given the green light for public use by the appropriate regulatory agency?
"Our team has assigned a rating of 2 to Nivolumab's safety due to its Phase 2 status. While there is evidence for the drug's protective qualities, none exists at this time that confirms efficacy."
Answered by AI
Are there still openings for volunteers to join this scientific experiment?
"Affirmative. Clinicaltrials.gov's records suggest that this clinical trial, which was initially published on the 28th of October 2021, is still enrolling for participation. 61 individuals need to be recruited from a single site."
Answered by AI
Are there any other investigations concerning Nivolumab that have been conducted?
"As of present, 1510 clinical experiments exploring Nivolumab are in progress with 234 studies occurring at the third phase. Despite Philadelphia, Pennsylvania having a high amount of trials for Nivolumab, there are 67150 sites running investigations related to this drug."
Answered by AI
What is the present enrollment rate for this medical experiment?
"Affirmative. The clinical trial's posting on clinicaltrials.gov reveals that participant recruitment is ongoing, with the study being first published October 28th 2021 and most recently modified March 28th 2022. 61 volunteers are needed at 1 facility to complete this experiment."
Answered by AI
What key elements are researchers attempting to determine with this medical experiment?
"The primary objective of this 26-month trial is to measure the Objective Response Rate (ORR) - (Cohort 1). Additionally, secondary metrics such as Overall Survival (OS), 2-year Overall Survival and Treatment-related Adverse Events will be tracked. Event assessment adheres to NCI Common Terminology for Adverse Events standards."
Answered by AI
What have studies indicated is the primary purpose of Nivolumab?
"Nivolumab is a clinically approved therapy for multiple sclerosis, acute and malignant neoplasms, myelocytic diseases as well as leukemia."
Answered by AI
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