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Monoclonal Antibodies
Combination Antibody Therapy for Large B-Cell Lymphoma (PACIFIC Trial)
Phase 2
Recruiting
Led By Ranjit Nair
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
Calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula
Patients must be willing to receive transfusions of blood products
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-treatment
Awards & highlights
PACIFIC Trial Summary
This trial is testing a combination of drugs to treat primary mediastinal large B-cell lymphoma, which is a cancer of the lymph nodes in the chest. The drugs being tested are brentuximab vedotin, nivolumab, rituximab, cyclophosphamide, doxorubicin, and prednisone. This combination of drugs may help to control the disease and be less harmful than standard chemotherapy.
Who is the study for?
Adults diagnosed with primary mediastinal large B-cell lymphoma (PMBL) who haven't been treated yet, except possibly a short course of steroids or limited-field radiotherapy. They must have measurable disease, be in stages I-IV (stage I tumors must be at least 5 cm), and have adequate organ function. Participants need to agree to use effective birth control and can't join if they're pregnant, have HIV with active viremia, hepatitis B or C viremia, other recent cancers, significant neuropathy, uncontrolled major diseases, or known allergies to the drugs tested.Check my eligibility
What is being tested?
The trial is testing brentuximab vedotin and nivolumab alone and combined with rituximab, cyclophosphamide, doxorubicin, and prednisone for treating PMBL. Brentuximab vedotin targets cancer cells specifically; nivolumab boosts the immune system's response against cancer; rituximab attaches to specific proteins on cancerous blood cells; chemotherapy aims to kill or stop the division of cancer cells; prednisone helps reduce inflammation.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs due to nivolumab's action on immunity; nerve damage from brentuximab vedotin; infusion-related reactions from monoclonal antibodies like rituximab; common chemo side effects such as nausea/vomiting from doxorubicin/cyclophosphamide; increased infection risk due to weakened immunity.
PACIFIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are functioning well enough, with a creatinine clearance of at least 30 ml/min.
Select...
I am willing to receive blood transfusions.
Select...
My cancer can be measured and is at least 1.5 cm in size.
Select...
My diagnosis of PMBL is confirmed through tissue examination.
Select...
My tumor or immune cells in the tumor show CD30 levels of 1% or more.
Select...
My cancer is at stage II, III, IV, or stage I but larger than 5 cm.
Select...
I or my healthcare proxy can understand and sign the consent form.
Select...
I am 18 years old or older.
PACIFIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate
Secondary outcome measures
1-year overall survival
1-year progression-free survival
2 -year progression-free survival
+5 moreOther outcome measures
Cell free deoxyribonucleic acid
Immune cell subsets
Minimal residual disease clonotype levels
+1 moreSide effects data
From 2020 Phase 4 trial • 60 Patients • NCT0199053418%
Pyrexia
12%
Peripheral sensory neuropathy
10%
Diarrhoea
10%
Neuropathy peripheral
10%
Neutropenia
8%
Polyneuropathy
8%
Nausea
8%
Anaemia
8%
Upper respiratory tract infection
7%
Arthralgia
7%
Vomiting
7%
Decreased appetite
5%
Hypomagnesaemia
5%
Hypokalaemia
5%
Paraesthesia
5%
Asthenia
5%
Bronchitis
5%
Cough
5%
Alopecia
3%
Oral herpes
3%
Abdominal pain
3%
Back pain
3%
Aspartate aminotransferase increased
3%
Alanine aminotransferase increased
3%
Constipation
3%
Nasopharyngitis
3%
Neutrophil count decreased
3%
Bone pain
3%
Headache
3%
Depression
3%
Thrombocytopenia
3%
Tachycardia
3%
Subcutaneous abscess
3%
Pruritus
3%
Rash
2%
Anaphylactic reaction
2%
Klebsiella infection
2%
Toothache
2%
Ligament sprain
2%
Chills
2%
Fatigue
2%
Blood alkaline phosphatase increased
2%
Lymphocyte count decreased
2%
Oedema
2%
Procedural pain
2%
Gamma-glutamyltransferase increased
2%
Catheter site inflammation
2%
Chest pain
2%
Renal tubular disorder
2%
Malaise
2%
Hyperuricaemia
2%
Influenza
2%
Lymphoedema
2%
Dengue fever
2%
Blood lactate dehydrogenase increased
2%
Facial nerve disorder
2%
Extravasation
2%
General physical health deterioration
2%
Hodgkin's disease
2%
Blood thyroid stimulating hormone increased
2%
Genital haemorrhage
2%
Upper respiratory tract inflammation
2%
Oedema peripheral
2%
Soft tissue inflammation
2%
Temperature regulation disorder
2%
Vaccination site pain
2%
Liver disorder
2%
Breast cellulitis
2%
Platelet count decreased
2%
Weight decreased
2%
Hyperglycaemia
2%
Pain in extremity
2%
Autonomic neuropathy
2%
Dysgeusia
2%
Somnolence
2%
Insomnia
2%
Device related infection
2%
Herpes zoster
2%
Hordeolum
2%
Conjunctivitis
2%
Coxsackie viral infection
2%
Leukocytosis
2%
Leukopenia
2%
Ear pain
2%
Autoimmune thyroiditis
2%
Diplopia
2%
Pseudomonas infection
2%
Sinusitis
2%
Viral infection
2%
Contusion
2%
Haemoglobin decreased
2%
Pneumonia
2%
Device related sepsis
2%
Septic shock
2%
Urinary tract infection
2%
Serum sickness-like reaction
2%
Cerebrovascular accident
2%
Anxiety
2%
Pleural effusion
2%
Vena cava thrombosis
2%
Dyspnoea
2%
Dyspnoea exertional
2%
Nasal congestion
2%
Dermatitis
2%
Dermatitis acneiform
2%
Dermatitis allergic
2%
Dermatitis contact
2%
Erythema
2%
Pruritus generalised
2%
Rash macular
2%
Rash maculo-papular
2%
Rash papular
2%
Rash pruritic
2%
Urticaria
2%
Haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin 1.8 mg/kg
PACIFIC Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (brentuximab vedotin, nivolumab, R-CHP)Experimental Treatment7 Interventions
Patient will receive an immune lead-in of 2 cycles of Brentuximab vedotin and Nivolumab (A-O) (cycles 1 and 2), which has an appropriate futility rules in place to close early if efficacy targets are not met. At cycle 3 and 4, patients will receive A-O with R-CHP. Patients who will have achieved complete response (CR) at PET/CT before cycle 5 will receive 2 more cycles of A-O-R-CHP (cycle 5 and 6) and A-O only for cycle 7 and 8. If these patients still present CR at PET/CT after cycle 8, they will have completed therapy and will be followed up. In case of stable disease or progressive disease at PET/CT after cycle 4, the patient will be taken off the trial. Patients who present further response but no CR, at PET/CT before cycle 5 will receive 4 more cycles A-O-R-CHP (cycles 5-8). If they reach CR at PET/CT after cycle 8, they will have completed therapy and will be followed up. All patients will receive a total of 8 cycles of A-O. The cycle duration is 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab Vedotin
2015
Completed Phase 4
~1100
Prednisone
2014
Completed Phase 4
~2370
Nivolumab
2014
Completed Phase 3
~4750
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,281 Total Patients Enrolled
Ranjit NairPrincipal InvestigatorM.D. Anderson Cancer Center
Raphael E Steiner, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidneys are functioning well enough, with a creatinine clearance of at least 30 ml/min.I do not have any severe health conditions that my doctor thinks could make the trial unsafe for me.I have not had major surgery or unhealed wounds in the last 4 weeks.I am allergic to specific cancer drugs like brentuximab vedotin or nivolumab.I cannot take certain medications or treatments due to other health issues.I have been treated with anthracycline drugs and my total dose is expected to exceed the safe limit due to this study.I have HIV with controlled viral load and CD4 count >= 300, and I'm on HAART.I have an active hepatitis B infection.My lymphoma has spread to my brain or spinal cord.I am willing to receive blood transfusions.My cancer can be measured and is at least 1.5 cm in size.My ability to perform daily activities is limited, but it's due to my lymphoma.I am using or willing to use effective birth control for the required duration.I've only had limited radiotherapy and a short steroid treatment.I have hepatitis C but no active infection, cleared by a GI doctor.I had cancer before, but it's either been treated successfully or is in remission, except for skin or early-stage cervical or breast cancer in the last 2 years.I have severe nerve pain or discomfort recently.I have not had a stroke or brain bleed in the last 6 months.I have not received any live vaccines in the last 4 weeks.My diagnosis of PMBL is confirmed through tissue examination.My tumor or immune cells in the tumor show CD30 levels of 1% or more.I've only had limited radiotherapy and short-term steroids before starting this trial.My cancer is at stage II, III, IV, or stage I but larger than 5 cm.I or my healthcare proxy can understand and sign the consent form.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (brentuximab vedotin, nivolumab, R-CHP)
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.
What is Brentuximab Vedotin's primary purpose?
"Brentuximab Vedotin has been shown to be an effective treatment for squamous cell carcinoma, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."
Answered by AI
Are researchers enrolling new participants in this trial at this time?
"This study, which is currently recruiting patients, was originally posted on May 10th 2021. The last update to the listing was on August 18th 2022."
Answered by AI
How many people fit the requirements to participate in this research?
"That is correct, the study detailed on clinicaltrials.gov is recruiting patients. This particular trial was first advertised on May 10th 2021 and had its last information update on August 18th 2022. The research team needs to enroll 40 individuals from 1 location."
Answered by AI
Does the FDA sanction Brentuximab Vedotin for public use?
"While Phase 2 trials are not as well-supported by data as Phase 3, our team has still given Brentuximab Vedotin a safety score of 2."
Answered by AI
Are there other ongoing research projects similar to this one involving Brentuximab Vedotin?
"Brentuximab Vedotin is being trialed in 2316 ongoing studies, with the majority of these investigations (424) taking place during Phase 3. Most clinical trials for Brentuximab Vedotin are based in Bethesda, Maryland; however, there are 92693 total locations operating clinical trials for this medication."
Answered by AI
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