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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
Must not have
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.
Select...
My skin cancer has worsened despite treatment with a PD-1 inhibitor.
Select...
I am currently on PD-1 therapy or had my last dose within the last 90 days.
Select...
I have advanced head and neck cancer with a specific treatment history.
Select...
My lung cancer is advanced, not caused by common mutations, and meets certain treatment history criteria.
Select...
I can carry out all my usual activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have cancer that has spread to my brain or spinal cord.
Select...
I have not had another cancer or any signs of cancer in the last 3 years.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria
Secondary study objectives
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%
Cough
17%
Dyspnoea
17%
Headache
16%
Asthenia
14%
Febrile neutropenia
14%
Arthralgia
14%
Dizziness
13%
Stomatitis
13%
Hypokalaemia
13%
Anxiety
12%
Myalgia
12%
Rash
12%
Abdominal pain
10%
Pruritus
10%
Gastrooesophageal reflux disease
10%
Pain in extremity
10%
Abdominal pain upper
9%
Oropharyngeal pain
9%
Thrombocytopenia
8%
Leukopenia
8%
Upper respiratory tract infection
8%
Dyspepsia
7%
Mucosal inflammation
7%
Bone pain
7%
Depression
7%
Hypotension
6%
Chest pain
6%
Diabetes mellitus
6%
Paraesthesia
6%
Dysgeusia
5%
Hypothyroidism
5%
Urinary tract infection
5%
Alanine aminotransferase increased
5%
Hyperglycaemia
5%
Hyperuricaemia
5%
Neck pain
5%
Pneumonia
4%
Dry skin
4%
Haemorrhoids
4%
Malaise
4%
Nasopharyngitis
4%
Hypercholesterolaemia
4%
Hyperlipidaemia
4%
Benign prostatic hyperplasia
4%
Peripheral motor neuropathy
2%
Pneumonitis
2%
Sepsis
1%
Pneumocystis jirovecii pneumonia
1%
Cellulitis
1%
Acute kidney injury
1%
Clostridium difficile colitis
1%
Deep vein thrombosis
1%
Respiratory failure
1%
Tumour lysis syndrome
1%
Dehydration
1%
Pulmonary embolism
1%
Neutropenic infection
1%
Cutaneous T-cell lymphoma
1%
Device related infection
1%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
A+CHP
CHOP
A+CHP Subgroup

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1900
pembrolizumab
2017
Completed Phase 3
~5890

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,193 Total Patients Enrolled
125 Trials studying Melanoma
22,783 Patients Enrolled for Melanoma
Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,290 Total Patients Enrolled
6 Trials studying Melanoma
1,170 Patients Enrolled for Melanoma
Medical MonitorStudy DirectorSeagen Inc.
1,675 Previous Clinical Trials
988,658 Total Patients Enrolled
13 Trials studying Melanoma
2,088 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
~27 spots leftby Oct 2025
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