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Monoclonal Antibodies

Brentuximab Vedotin + Pembrolizumab for Advanced Cancers

Phase 2

Recruiting

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

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

Must have

Participants in Cohorts 1-4 must have progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other CPIs or other therapies, meeting specific progression criteria

Participants with relapsed/refractory metastatic cutaneous melanoma with progression on a PD-1 inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

Study Summary

This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer, including metastatic cancer that has progressed after PD-1 inhibitor treatment. The study will also find out what side effects occur.

Who is the study for?

This trial is for adults with certain metastatic cancers (oral, melanoma, lung) that have not responded to previous treatments. They must have tried a PD-1 inhibitor and can't have any active brain metastases or recent other cancer treatments. Good physical health as measured by ECOG score of 1 or less is required.Check my eligibility

What is being tested?

The study tests the combination of brentuximab vedotin and pembrolizumab in treating advanced cancers that spread to other body parts. It aims to see how well these drugs work together across different cancer types in multiple groups of patients.See study design

What are the potential side effects?

Possible side effects include immune system reactions, infusion-related symptoms, fatigue, skin issues, nerve damage, and complications from organ inflammation. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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My cancer progressed despite treatment with an anti-PD-1 therapy.

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My skin cancer has worsened despite treatment with a PD-1 inhibitor.

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I am currently on PD-1 therapy or had my last dose within the last 90 days.

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I have advanced head and neck cancer with a specific treatment history.

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My lung cancer is advanced, not caused by common mutations, and meets certain treatment history criteria.

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I can carry out all my usual activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria

Secondary outcome measures

Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria

Incidence of adverse events (AEs)

ORR per iRECIST by investigator assessment

+3 more

Side effects data

From 2020 Phase 3 trial • 452 Patients • NCT01777152

51%

Nausea

50%

Peripheral sensory neuropathy

44%

Constipation

42%

Diarrhoea

39%

Neutropenia

39%

Pyrexia

37%

Fatigue

32%

Hypertension

29%

Anaemia

27%

Vomiting

26%

Alopecia

24%

Weight decreased

24%

Decreased appetite

23%

Insomnia

21%

Night sweats

20%

Back pain

18%

Oedema peripheral

17%

Dyspnoea

17%

Headache

17%

Cough

16%

Asthenia

14%

Dizziness

14%

Febrile neutropenia

14%

Arthralgia

13%

Stomatitis

13%

Hypokalaemia

13%

Anxiety

12%

Myalgia

12%

Rash

12%

Abdominal pain

10%

Gastrooesophageal reflux disease

10%

Pruritus

10%

Pain in extremity

10%

Abdominal pain upper

Thrombocytopenia

Oropharyngeal pain

Upper respiratory tract infection

Leukopenia

Dyspepsia

Bone pain

Mucosal inflammation

Depression

Hypotension

Dysgeusia

Chest pain

Diabetes mellitus

Paraesthesia

Neck pain

Hyperglycaemia

Hypothyroidism

Urinary tract infection

Alanine aminotransferase increased

Hyperuricaemia

Pneumonia

Nasopharyngitis

Haemorrhoids

Hypercholesterolaemia

Dry skin

Hyperlipidaemia

Malaise

Benign prostatic hyperplasia

Peripheral motor neuropathy

Pneumonitis

Sepsis

Pulmonary embolism

Cellulitis

Pneumocystis jirovecii pneumonia

Respiratory failure

Neutropenic infection

Clostridium difficile colitis

Cutaneous T-cell lymphoma

Acute kidney injury

Deep vein thrombosis

Tumour lysis syndrome

Dehydration

Device related infection

Influenza

100%

80%

60%

40%

20%

Study treatment Arm

A+CHP

CHOP

A+CHP Subgroup

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination TherapyExperimental Treatment2 Interventions

brentuximab vedotin + pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

brentuximab vedotin

2010

Completed Phase 3

~1880

pembrolizumab

2017

Completed Phase 3

~5750

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,531 Total Patients Enrolled

120 Trials studying Melanoma

21,543 Patients Enrolled for Melanoma

Seagen Inc.Lead Sponsor

208 Previous Clinical Trials

74,088 Total Patients Enrolled

6 Trials studying Melanoma

1,054 Patients Enrolled for Melanoma

Medical MonitorStudy DirectorSeagen Inc.

1,660 Previous Clinical Trials

983,689 Total Patients Enrolled

11 Trials studying Melanoma

1,175 Patients Enrolled for Melanoma

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04609566 — Phase 2

Melanoma Research Study Groups: Combination Therapy

Melanoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT04609566 — Phase 2

Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04609566 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions can be treated or managed with brentuximab vedotin?

"Brentuximab vedotin is commonly prescribed as a management approach for unresectable melanoma. Additionally, it is utilized to address microsatellite instability high and other conditions associated with elevated risk of recurrence."

Answered by AI

How many healthcare facilities are administering this experiment?

"Presently, the researchers are running this trial out of 30 sites across America. Locations include Seattle, Norfolk and Springdale as well as other cities. To reduce travel time when enrolling in the study it is suggested that you select a nearby location."

Answered by AI

Could you provide information regarding other experiments conducted with brentuximab vedotin?

"Currently, the drug brentuximab vedotin is being studied in 1016 live medical trials with 127 still in Phase 3. Primarily researched at Rochester, Minnesota-based facilities, clinical trial sites are also situated across 37540 locations worldwide."

Answered by AI

What adverse effects has brentuximab vedotin been associated with?

"Evaluators from Power rated brentuximab vedotin's safety with a 2 since this is still an early phase trial and there is only preliminary evidence confirming its security, but none demonstrating its efficacy."

Answered by AI

Is enrollment for this medical trial still available to participants?

"According to the information held on clinicaltrials.gov, this medical trial is actively searching for participants. It was initially published a few months ago in January 2021 and has recently been modified as of November 2022."

Answered by AI

What is the current enrollment count for this trial?

"Indeed, the information hosted on clinicaltrials.gov confirms that this medical trial is actively enrolling patients. The experiment was first posted in January 2021 and it seeks 140 test subjects from 30 different sites across the country."

Answered by AI

What goals does this trial aim to accomplish?

"This trial has been designed to evaluate the efficacy of a given treatment through objective response rate (ORR) using RECIST 1.1 criteria over an estimated 2 year period. Additional endpoints include progression-free survival (PFS), ORR per iRECIST, and iPFS per iRECIST by investigator assessment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

2021. "Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04609566.

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