What side effects are associated with this type of intervention?

Common treatments for Hodgkin's Lymphoma, such as the ABVD chemotherapy regimen, can cause side effects like nausea, vomiting, hair loss, fatigue, and increased infection risk due to bone marrow suppression. Specific drugs in ABVD can also lead to lung toxicity (Bleomycin) and heart damage (Adriamycin). Nivolumab, a PD-1 inhibitor, can cause immune-related side effects including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions, with severe cases potentially leading to severe pneumonitis and myocarditis.

What prior FDA approvals exist?

Nivolumab, a PD-1 inhibitor, has been studied for its efficacy in treating Hodgkin's Lymphoma, particularly in patients with abnormal PET scans after two cycles of ABVD. This aligns with the broader use of immune checkpoint inhibitors in oncology. Pembrolizumab, another PD-1 inhibitor, has also been approved for various cancers, including Hodgkin's Lymphoma, especially for patients who have relapsed or are refractory to other treatments. These approvals highlight the growing role of immunotherapy in managing Hodgkin's Lymphoma.

What other types of research exist?

Promising novel alternatives to Nivolumab for Hodgkin's Lymphoma patients include Pembrolizumab (another PD-1 inhibitor), Brentuximab Vedotin (an antibody-drug conjugate targeting CD30), and combination therapies involving checkpoint inhibitors with other agents such as chemotherapy or targeted therapies. These alternatives have shown efficacy in clinical trials and are considered viable options for treatment.

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Anti-tumor antibiotic

A(B)VD + Nivolumab for Hodgkin's Lymphoma

Q: What is the mechanism of action of this treatment?

The most common treatments for Hodgkin's Lymphoma include ABVD chemotherapy and immune checkpoint inhibitors like Nivolumab. ABVD, which stands for Adriamycin, Bleomycin, Vinblastine, and Dacarbazine, works by damaging the DNA of cancer cells, thereby preventing them from dividing and growing. Nivolumab, on the other hand, is a PD-1 inhibitor that blocks the programmed cell death protein 1 (PD-1) pathway, which cancer cells often exploit to evade the immune system. By inhibiting this pathway, Nivolumab helps the immune system recognize and attack cancer cells more effectively. These treatments are crucial for Hodgkin's Lymphoma patients as they target the cancer cells directly and enhance the body's immune response, thereby improving the chances of remission and cure.

Phase 1 & 2

Recruiting

Led By Alison Moskowitz, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18

Serum creatinine ≤ 1.5 x Upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 40 mL/min (measured using the Cockcroft-Gault formula

Must not have

Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.

A left-ventricular ejection fraction < 50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

Summary

This trial is testing a new cancer treatment for Hodgkin lymphoma. The goal is to see if it can improve the chances of a cure, especially for patients with higher risk Hodgkin lymphoma.

Who is the study for?

This trial is for adults with untreated classical Hodgkin lymphoma who are at higher risk (stage III or IV, or positive PET scans after initial treatment). It's open to those under 60 for one cohort and over 60 for another. Participants need functioning major organs, not be pregnant or breastfeeding, and must use reliable birth control.Check my eligibility

What is being tested?

The study is testing the effectiveness of Nivolumab combined with a chemotherapy regimen called ABVD (which includes dacarbazine, doxorubicin, bleomycin, vinblastine) as a first-line treatment to see if it can improve cure rates in patients with high-risk Hodgkin lymphoma.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in various organs due to Nivolumab. Chemotherapy drugs may cause nausea, hair loss, fatigue, increased infection risk and heart complications among other side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My kidney function, measured by creatinine levels, is within the normal range.

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I have been diagnosed with classical Hodgkin lymphoma.

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My condition is in an advanced stage, specifically Ann Arbor Stage III or IV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had active cancer in the last 3 years, except for certain curable types.

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My heart's pumping ability is below normal.

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I do not have uncontrolled heart problems.

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I have tested positive for HIV/AIDS.

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I have active brain or leptomeningeal metastases.

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I have been diagnosed with nodular lymphocyte-predominant Hodgkin's lymphoma.

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I have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase II- progression free survival

number of patients who have dose limiting toxicity

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

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%

Neutropenia

21%

Pyrexia

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

Hypothyroidism

Abdominal pain upper

Upper respiratory tract infection

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Chills

Hypertension

Bronchitis

Dehydration

Blood alkaline phosphatase increased

Hyperglycaemia

Hyperkalaemia

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Hypotension

Dry mouth

Pain

Malaise

Musculoskeletal chest pain

Rash maculo-papular

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Myocardial infarction

Metastases to central nervous system

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Embolism

Cardiac failure

Malignant pleural effusion

Sepsis

Atrial fibrillation

General physical health deterioration

Adrenal insufficiency

Neoplasm progression

Cancer pain

Confusional state

Circulatory collapse

Bronchial obstruction

Pneumothorax

Atrial flutter

Ileus

Bone pain

Small intestinal haemorrhage

Pericardial effusion

Femur fracture

Pancytopenia

Colitis

Small intestinal obstruction

Hypercalcaemia

Syncope

Pericardial effusion malignant

Superior vena cava syndrome

Gastrointestinal haemorrhage

Lung cancer metastatic

Performance status decreased

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Trial Design

2Treatment groups

Experimental Treatment

Group I: < 60 years of age with advanced stage (HL) untreatedExperimental Treatment5 Interventions

The study will employ a 3+3 design and include 3 treatment cohorts. In each cohort, patients will receive 6 cycles of A(B)VD and 8 doses of nivolumab. In dose level 1, patients will receive nivolumab in combination with AVD during cycle 6 only followed by 6 additional doses of nivolumab. In subsequent dose levels, nivolumab will be combined with increasing numbers of cycles of AVD. Based upon safety data from another study with Nivolumab, we will no longer need to evaluate dose level 2. If we determine that dose level 1 is safe, the next group of patients will enroll onto dose level 3. A PET scan will be performed after 2 cycles of ABVD and those with a PET-negative response (defined by Deauville 1, 2 or 3) will proceed with 4 additional cycles of ABVD or AVD (per treating physician preference).

Group II: 60 years of age and older with HL (any stage) untreatedExperimental Treatment4 Interventions

The study will employ a 3+3 design and include 3 treatment cohorts. In each cohort, patients will receive 6 cycles of AVD and 12 doses of nivolumab. In this cohort, patients will receive nivolumab in combination with AVD during cycles 5 and 6 only, followed by 8 additional doses of nivolumab. In subsequent cohorts, nivolumab will be combined with increasing numbers of cycles of AVD. Based upon safety data from another study with Nivolumab, we will no longer need to evaluate dose level 2. If we determine that dose level 1 is safe, the next group of patients will enroll onto dose level 3. Prophylactic growth factor support is mandatory for all patients on Cohort B and should be used per the treating physician's discretion for all other patients.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

doxorubicin

2005

Completed Phase 3

~9130

dacarbazine

2008

Completed Phase 3

~6240

Bleomycin

2001

Completed Phase 3

~4960

vinblastine

2010

Completed Phase 3

~1490

Nivolumab

2014

Completed Phase 3

~4740

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hodgkin's Lymphoma include ABVD chemotherapy and immune checkpoint inhibitors like Nivolumab. ABVD, which stands for Adriamycin, Bleomycin, Vinblastine, and Dacarbazine, works by damaging the DNA of cancer cells, thereby preventing them from dividing and growing. Nivolumab, on the other hand, is a PD-1 inhibitor that blocks the programmed cell death protein 1 (PD-1) pathway, which cancer cells often exploit to evade the immune system. By inhibiting this pathway, Nivolumab helps the immune system recognize and attack cancer cells more effectively. These treatments are crucial for Hodgkin's Lymphoma patients as they target the cancer cells directly and enhance the body's immune response, thereby improving the chances of remission and cure.