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PD-1 Inhibitor

Talimogene Laherparepvec + Pembrolizumab for Melanoma

Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years with histologically confirmed diagnosis of stage IIIB to IVM1d melanoma and for whom surgery is not recommended
Subjects must have had prior treatment (for at least 2 to 3 consecutive cycles within an 8 week period) with a PD-1 inhibitor and have confirmed disease progression (as defined by RECIST v1.1 criteria). The anti-PD-1 therapy must be the immediate prior line of therapy before enrollment and subjects with disease progression on more than 1 line of anti-PD-1 therapy are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks up to 4 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining two drugs, talimogene laherparepvec and pembrolizumab. The treatment will be given to people with unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior adjuvant therapy who have progressed on prior anti-PD-1 therapy. The study will evaluate the efficacy and safety of the treatment.

Who is the study for?
This trial is for adults over 18 with stage IIIB to IVM1d melanoma that can't be removed by surgery. They must have tried a PD-1 inhibitor therapy and seen their cancer grow despite this treatment. Participants should be in good physical condition, able to perform daily activities (ECOG status of 0 or 1), and have no more than three treated brain metastases without recent steroid use.Check my eligibility
What is being tested?
The study tests talimogene laherparepvec combined with pembrolizumab in patients whose melanoma worsened after anti-PD-1 therapy. It's an open-label, phase 2 trial where all participants receive the same treatment until they either respond completely, run out of lesions that can be injected, experience intolerable side effects, see further disease progression, or complete 102 weeks of treatment.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site for talimogene laherparepvec, flu-like symptoms such as fever and chills, fatigue from pembrolizumab; both drugs may also cause immune-related issues affecting organs like the liver or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and have advanced melanoma that cannot be removed by surgery.
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I've had PD-1 inhibitor treatment for my cancer, which didn't work.
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I have visible tumors that can be treated by direct injection.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks up to 4 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
Objective Response Rate (ORR) Per Modified RECIST v1.1
Secondary outcome measures
BOR Per Modified RECIST v1.1
Best Overall Response (iBOR) Per Modified irRC-RECIST
Complete Response Rate (CRR) Per Modified RECIST v1.1
+13 more

Side effects data

From 2014 Phase 3 trial • 437 Patients • NCT00769704
50%
Fatigue
48%
Chills
41%
Pyrexia
36%
Nausea
30%
Influenza like illness
28%
Injection site pain
21%
Vomiting
19%
Diarrhoea
19%
Headache
17%
Arthralgia
17%
Myalgia
16%
Pain
16%
Pain in extremity
12%
Constipation
12%
Oedema peripheral
11%
Cough
10%
Upper respiratory tract infection
10%
Decreased appetite
10%
Dizziness
10%
Pruritus
9%
Back pain
9%
Abdominal pain
9%
Rash
8%
Hyperhidrosis
7%
Erythema
7%
Tumour pain
7%
Anxiety
7%
Insomnia
6%
Oropharyngeal pain
6%
Weight decreased
5%
Dyspepsia
5%
Injection site erythema
5%
Musculoskeletal pain
5%
Neck pain
5%
Depression
5%
Anaemia
5%
Vitiligo
4%
Muscle spasms
4%
Dyspnoea
3%
Injection site reaction
3%
Injection site swelling
3%
Disease progression
2%
Injection site pruritus
2%
Cellulitis
1%
Gastrointestinal haemorrhage
1%
Intestinal obstruction
1%
Rib fracture
1%
Metastases to central nervous system
1%
Deep vein thrombosis
1%
Pleural effusion
1%
Dehydration
1%
Infected neoplasm
1%
Metastatic malignant melanoma
1%
Cerebral haemorrhage
1%
Convulsion
1%
Mental status changes
1%
Pulmonary embolism
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Talimogene Laherparepvec
GM-CSF

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4 - Adjuvant Setting -Disease Free Interval ≥ 6 monthsExperimental Treatment2 Interventions
Includes participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles.
Group II: Cohort 3 - Adjuvant Setting -Disease Free Interval < 6 monthsExperimental Treatment2 Interventions
Includes participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles.
Group III: Cohort 2 - Locally Recurrent/Metastatic - Acquired ResistanceExperimental Treatment2 Interventions
Includes participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles.
Group IV: Cohort 1 - Locally Recurrent/Metastatic - Primary ResistanceExperimental Treatment2 Interventions
Includes participants who received anti-PD1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talimogene laherparepvec
2014
Completed Phase 3
~810
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,382 Previous Clinical Trials
1,379,611 Total Patients Enrolled
23 Trials studying Melanoma
19,434 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,898 Previous Clinical Trials
5,062,546 Total Patients Enrolled
120 Trials studying Melanoma
21,811 Patients Enrolled for Melanoma
MDStudy DirectorAmgen
928 Previous Clinical Trials
926,658 Total Patients Enrolled
13 Trials studying Melanoma
2,907 Patients Enrolled for Melanoma

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04068181 — Phase 2
Melanoma Research Study Groups: Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance, Cohort 4 - Adjuvant Setting -Disease Free Interval ≥ 6 months, Cohort 3 - Adjuvant Setting -Disease Free Interval < 6 months, Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04068181 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04068181 — Phase 2

Frequently Asked Questions

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

For which age groups does this research trial accommodate?

"The prerequisites for taking part in this trial mandate that the participant be at least 18 years old and not exceed 99."

Answered by AI

What is the aggregate amount of participants in this investigation?

"The present recruitment phase for this study has concluded. It was posted on January 22nd 2020 and last edited on August 15th 2022. However, there are presently 754 clinical trials that are admitting patients with melanoma, as well as 978 studies involving Talimogene laherparepvec currently recruiting participants."

Answered by AI

How many sites are currently offering this clinical research opportunity?

"The search for participants is ongoing at Baylor Scott and White Research Institute in Austin, Princess Margaret Cancer Centre in Dallas, Jewish General Hospital in Orlando, and 23 other medical sites."

Answered by AI

What conditions has Talimogene laherparepvec been proven to ameliorate?

"Talimogene laherparepvec is a commonly used treatment for malignant neoplasms, as well as unresectable melanoma, microsatellite instability high syndrome and any progression of disease following chemotherapy."

Answered by AI

Is there still an opportunity for interested individuals to join this research project?

"This clinical trial is no longer accepting new participants. It was published on the 22nd of January 2020 and then most recently updated 15th August 2022. If you are looking to participate in another study, there are 754 trials searching for patients with melanoma and 978 studies involving Talimogene laherparepvec that require volunteers."

Answered by AI

Who is able to partake in this research endeavor?

"This clinical research necessitates that participants have a diagnosis of melanoma and fall within the age bracket of 18 to 99 years. Currently, 72 people are required for this experiment."

Answered by AI

Are there any additional research studies being conducted regarding Talimogene laherparepvec?

"At present, there are 978 active clinical trials analyzing Talimogene laherparepvec with 122 of them in the final stages. The majority are based within Houston, yet 35824 locations across the world have been recruited to study this drug."

Answered by AI

Has the U.S. Food & Drug Administration sanctioned Talimogene laherparepvec?

"Talimogene laherparepvec's safety is estimated as a 2 due to the lack of clinical data supporting efficacy, but there are studies that demonstrate its security."

Answered by AI

What are the fundamental aims of this investigation?

"According to Amgen, the sponsor of this clinical trial, its primary outcome will be measured over a period extending up to 4 years and is known as Objective Response Rate (ORR) Per Modified RECIST v1.1. Other secondary outcomes such as Duration Of Response (DOR), Progression Free Survival (PFS) by investigator assessment using modified Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 and BOR Per Modified RECIST v 1.1 are also being assessed with further details provided on clinicialtrials.gov"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).
2020. "Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04068181.
~14 spots leftby May 2025
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