A Phase 2 interventional study of Brentuximab Vedotin and Dacarbazine in Ann Arbor Stage I Hodgkin Lymphoma, Ann Arbor Stage IA Hodgkin Lymphoma and Ann Arbor Stage IB Hodgkin Lymphoma, sponsored by Academic and Community Cancer Research United. Active, not recruiting at 9 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Academic and Community Cancer Research United · Phase 2, Interventional, and Treatment
This phase II trial evaluates how well AVD (doxorubicin, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab may improve survival of patients with stage I-II Hodgkin lymphoma.
PRIMARY OBJECTIVE:
I. To estimate progression-free survival (PFS) at 3 years in patients with previously untreated stage I or II non-bulky Hodgkin lymphoma (HL) who received doxorubicin, vinblastine, dacarbazine (AVD) plus brentuximab vedotin (BV) induction therapy followed by nivolumab (N)VB consolidation therapy.
SECONDARY OBJECTIVES:
I. To estimate the overall survival (OS) rate at 3 years in patients with previously untreated stage I or II non-bulky HL who received AVD plus BV induction therapy followed by NVB consolidation therapy.
II. To estimate the percentage of patients with untreated stage I or II non-bulky HL who are positron emission tomography (PET) positive versus PET negative after 3 cycles of AVD plus BV induction therapy.
III. To estimate PFS and OS at 3 and 5 years separately for patients who are PET negative versus PET positive after 3 cycles of AVD plus BV induction followed by NVB consolidation therapy.
IV. To estimate time to progression (TTP) in patients with previously untreated stage I or II non-bulky HL who received AVD plus BV induction therapy followed by NVB consolidation therapy.
V. To estimate the overall response rate and the number of patients who convert to complete response (CMR) after NVB in patients with partial response (PMR) at the end of AVD plus BV induction therapy.
VI. To estimate the duration of response in patients with previously untreated stage I or II non-bulky Hodgkin's lymphoma who received AVD plus BV induction therapy followed by NVB consolidation therapy.
VII. To evaluate the toxicity and tolerability of AVD plus BV induction followed by NVB consolidation therapy as assessed via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v]4).
EXPLORATORY OBJECTIVES:
I. Optional biopsy tissue samples will be collected for future analysis. II. Optional blood sample will be collected for future analysis. III. Cost-benefit analysis of AVD plus BV followed by NVB consolidation, compared to the current standard therapy with adriamycin, bleomycin, vinblastine plus dacarbazine (ABVD) with or without radiation therapy.
OUTLINE:
Patients receive doxorubicin intravenously (IV) over 3-5 minutes, vinblastine IV over 3-5 minutes, and dacarbazine IV over >= 30 minutes, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET-positive then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. PET-positive patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. PET-negative patients receive nivolumab IV over 30 minutes on day 1 starting after AVD and BV treatment. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 and 8 weeks, every 3 or 6 months for 2 years, and then once a year for 3 years.
1,383 studies on the registry are indexed under Hodgkin Disease; 163 are open to participants now.
This study's enrollment of 83 is above the median of 40 across 1,095 interventional studies indexed under Hodgkin Disease.
Browse Hodgkin Disease studies →Academic and Community Cancer Research United is the lead sponsor of 50 studies on the registry; 4 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Exclusion Criteria:
Any of the following because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and dacarbazine IV over \>= 30 minutes, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET-positive then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. PET-positive patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. PET-negative patients receive nivolumab IV over 30 minutes on day 1 starting after AVD and BV treatment. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Brentuximab Vedotin · Drug: Dacarbazine · Drug: Doxorubicin · Other: Laboratory Biomarker Analysis · Biological: Nivolumab · Drug: Vinblastine
Given IV
Also known as: ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35, Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35, cAC10-vcMMAE, SGN-35
Given IV
Also known as: 4-(Dimethyltriazeno)imidazole-5-carboxamide, 5-(Dimethyltriazeno)imidazole-4-carboxamide, Asercit, Biocarbazine, Dacarbazina, Dacarbazina Almirall, Dacarbazine - DTIC, Dacatic, Dakarbazin, Deticene, Detimedac, DIC, Dimethyl (triazeno) imidazolecarboxamide, Dimethyl Triazeno Imidazol Carboxamide, Dimethyl Triazeno Imidazole Carboxamide, dimethyl-triazeno-imidazole carboxamide, Dimethyl-triazeno-imidazole-carboximide, DTIC, DTIC-Dome, Fauldetic, Imidazole Carboxamide, Imidazole Carboxamide Dimethyltriazeno, WR-139007
Given IV
Also known as: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin
Correlative studies
Given IV
Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo
Given IV
Also known as: Vincaleucoblastine, VLB
Progression Free Survival
The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier. 3 year PFS with 95% CI will be reported.
Time frame: 3 years
Overall Survival
Overall survival time is defined as the time from registration to death due to any cause. The distribution of overall survival time will be estimated using the method of Kaplan-Meier. The rate of overall survival at 3 years and 5 years will be estimated.
Time frame: Time from registration to death due to any cause, assessed at 3 and 5 years
The Proportion of Patients Who Are Positron Emission Tomography (PET) Negative
The proportion of patients who are PET negative after 3 cycles of treatment will be estimated by the number of patients who are PET negative divided by the total number of evaluable patients. PET will be considered negative if the patient is given a Deauville score of ≤ 3.
Time frame: 3 courses (84 days)
Proportion of Patients Who Are Positron Emission Tomography (PET) Positive
The proportion of patients who are PET positive after 3 cycles of treatment will be estimated by the number of patients who are PET positive divided by the total number of evaluable patients.
Time frame: 3 courses (84 days)
Progression Free Survival
Progression-free survival will be evaluated by PET status after 3 cycles of treatment (PET positive vs. PET negative) in patients who complete the cycle 3 response assessment. PFS will be defined as the time from registration to relapse or death due to any cause.
Time frame: From registration, where progression is by CT-based or PET-CT based criteria, assessed at 3 years
Progression Free Survival
Progression-free survival will be evaluated by PET status after 3 cycles of treatment (PET positive vs. PET negative) in patients who complete the cycle 3 response assessment. PFS will be defined as the time from registration to relapse or death due to any cause.
Time frame: From registration, where progression is by CT-based or PET-CT based criteria, assessed at 5 years
Overall Response Rate (ORR)
The ORR will be estimated by the number of patients with an complete response (CR)/complete metabolic response/partial response (PR)/partial metabolic response or better divided by the total number of evaluable patients. The ORR may be analysed when all patients are off treatment.
Time frame: 5 years
Time to Progression
Time to progression is defined as the time from registration to the earliest date of documentation of disease progression (PD or PMD).\> Patients who are progression-free will be censored on the date of their last disease assessment. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Time frame: 5 years
The Proportion of Patients Who Convert From Partial Response at the End of Induction Therapy to Complete Response After Brentuximab Vedotin Plus Nivolumab (NVB)
The proportion of patients who convert from partial response (PMR) at the end of AVD plus BV induction therapy to complete response\> (CMR) after NVB will be estimated by the number of patients who convert divided by the total number of evaluable patients who receive at least one dose of NVB induction therapy. Exact binomial 95% confidence intervals for the true conversion rate will be calculated.
Time frame: 5 years
Median Duration of Response
Duration of response is defined for all evaluable patients who have achieved a PR or CR as the date at which the patient's objective status is first noted to be a response to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.
Time frame: 5 years
Number of Patients Experiencing Grade 3+ Adverse Events
Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The number of patients experiencing at least one grade 3 or greater AE regardless of attribution will be reported.
Time frame: 5 years
| Milestone | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Started | 80 |
| Completed | 77 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event | 2 |
| Milestone | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Started | 77 |
| Completed | 67 |
| Not completed | 10 |
| Withdrew: Adverse event | 6 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Other | 2 |
The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier. 3 year PFS with 95% CI will be reported.
| percentage of patients alive and PF | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Progression Free Survival | 96.48 (91.79 to 100) |
Overall survival time is defined as the time from registration to death due to any cause. The distribution of overall survival time will be estimated using the method of Kaplan-Meier. The rate of overall survival at 3 years and 5 years will be estimated.
| percentage of participants alive | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| 3 years | 100 (100 to 100) |
| 5 years | 100 (100 to 100) |
The proportion of patients who are PET negative after 3 cycles of treatment will be estimated by the number of patients who are PET negative divided by the total number of evaluable patients. PET will be considered negative if the patient is given a Deauville score of ≤ 3.
| Participants | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| The Proportion of Patients Who Are Positron Emission Tomography (PET) Negative | 73 |
The proportion of patients who are PET positive after 3 cycles of treatment will be estimated by the number of patients who are PET positive divided by the total number of evaluable patients.
| Participants | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Proportion of Patients Who Are Positron Emission Tomography (PET) Positive | 4 |
Progression-free survival will be evaluated by PET status after 3 cycles of treatment (PET positive vs. PET negative) in patients who complete the cycle 3 response assessment. PFS will be defined as the time from registration to relapse or death due to any cause.
| percentage of patients alive and PF | Treatment (Combination Chemotherapy, Nivolumab) - PET Negative | Treatment (Combination Chemotherapy, Nivolumab) - PET Positive |
|---|---|---|
| Progression Free Survival | 96.25 (91.27 to 100) | 100 (100 to 100) |
Progression-free survival will be evaluated by PET status after 3 cycles of treatment (PET positive vs. PET negative) in patients who complete the cycle 3 response assessment. PFS will be defined as the time from registration to relapse or death due to any cause.
| percentage of patients alive and PF | Treatment (Combination Chemotherapy, Nivolumab) - PET Negative | Treatment (Combination Chemotherapy, Nivolumab) - PET Positive |
|---|---|---|
| Progression Free Survival | 96.25 (91.27 to 100) | — |
The ORR will be estimated by the number of patients with an complete response (CR)/complete metabolic response/partial response (PR)/partial metabolic response or better divided by the total number of evaluable patients. The ORR may be analysed when all patients are off treatment.
| Participants | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Overall Response Rate (ORR) | 79 |
Time to progression is defined as the time from registration to the earliest date of documentation of disease progression (PD or PMD).\> Patients who are progression-free will be censored on the date of their last disease assessment. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
| months | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Time to Progression | NA (NA to NA) |
The proportion of patients who convert from partial response (PMR) at the end of AVD plus BV induction therapy to complete response\> (CMR) after NVB will be estimated by the number of patients who convert divided by the total number of evaluable patients who receive at least one dose of NVB induction therapy. Exact binomial 95% confidence intervals for the true conversion rate will be calculated.
| Participants | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| The Proportion of Patients Who Convert From Partial Response at the End of Induction Therapy to Complete Response After Brentuximab Vedotin Plus Nivolumab (NVB) | 3 |
Duration of response is defined for all evaluable patients who have achieved a PR or CR as the date at which the patient's objective status is first noted to be a response to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.
| months | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Median Duration of Response | NA (NA to NA) |
Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The number of patients experiencing at least one grade 3 or greater AE regardless of attribution will be reported.
| Participants | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Number of Patients Experiencing Grade 3+ Adverse Events | 49 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Combination Chemotherapy, Nivolumab) | 0/80 (0%) | 33/80 (41.3%) | 76/80 (95%) |
| Event | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 5/80 |
| Abdominal painGastrointestinal disorders | 4/80 |
| NauseaGastrointestinal disorders | 4/80 |
| ConstipationGastrointestinal disorders | 3/80 |
| VomitingGastrointestinal disorders | 3/80 |
| FeverGeneral disorders and administration site conditions | 3/80 |
| Lung infectionInfections and infestations | 3/80 |
| Peripheral motor neuropathyNervous system disorders | 3/80 |
| DiarrheaGastrointestinal disorders | 2/80 |
| IleusGastrointestinal disorders | 2/80 |
| Event | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| FatigueGeneral disorders and administration site conditions | 34/80 |
| Peripheral sensory neuropathyNervous system disorders | 34/80 |
| NauseaGastrointestinal disorders | 33/80 |
| Neutrophil count decreasedInvestigations | 31/80 |
| Alanine aminotransferase increasedInvestigations | 25/80 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 17/80 |
| ConstipationGastrointestinal disorders | 16/80 |
| DiarrheaGastrointestinal disorders | 16/80 |
| AlopeciaSkin and subcutaneous tissue disorders | 16/80 |
| Aspartate aminotransferase increasedInvestigations | 14/80 |
| Age, Continuous(years) | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Mean | 34.8 ± 11.12 |
| Sex: Female, Male(Participants) | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Female | 40 |
| Male | 40 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| Hispanic or Latino | 15 |
| Not Hispanic or Latino | 63 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 66 |
| More than one race | 0 |
| Unknown or Not Reported | 6 |
| Region of Enrollment(participants) | Treatment (Combination Chemotherapy, Nivolumab) |
|---|---|
| United States | 80 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drugs tested here: Brentuximab Vedotin · Dacarbazine · Doxorubicin · Nivolumab · Vinblastine
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