Melanoma (Skin)Phase 2NCT03972046

Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma

A Phase 2 study testing Talimogene laherparepvec (T-Vec), Dabrafenib (BRAF Inhibitor) and Trametinib (MEK Inhibitor) in people with Melanoma (Skin) and Melanoma Stage IIIb-IVM1a, run by TriHealth Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

This study will investigate whether the use of talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor will result in durable regional and distant recurrence free survival in the neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma (Skin), Melanoma Stage IIIb-IVM1a, Metastasis Skin
What is being tested?: Talimogene laherparepvec (T-Vec), Dabrafenib (BRAF Inhibitor) and Trametinib (MEK Inhibitor)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 24 Jun 2019to 3 Feb 2020
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18
Malignant melanoma Stage IIIb-IVM1a patients.
Primary or recurrent disease.
Cutaneous primary melanoma or unknown primary.
Measurable disease as evidenced by:
At least one lesion measuring greater than or equal to 10 mm on CT, ultrasound, or physical exam

Show all 19Show fewer

A conglomerate of superficial lesions measuring which in aggregate have a total diameter of 10 mm
Injectable disease
Palpable regional metastasis at the time of initial presentation or with regional recurrence
Tumor(s) with BRAF mutation
ECOG 0,1,2
Life expectancy > 2 years in the opinion of the investigator
Able to provide written informed consent
Adequate organ function based on most recent labs (according to investigator discretion), defined as follows:
Hematological: Absolute neutrophil count ≥ 1500/mm3 (1.5x109/L); Platelet count ≥ 75,000/mm3 (7.5x109/L); Hemoglobin ≥ 8 g/dL (without need for hematopoietic growth factor or transfusion support)
Renal: Serum creatinine ≤ 1.5 x upper limit of normal (ULN), OR 24-hour creatinine clearance ≥ 60 mL/min for subject with creatinine levels > 1.5 x ULN. (Note: Creatinine clearance need not be determined if the baseline serum creatinine is ≤ 1.5 x ULN. . Creatinine clearance should be determined per institutional standard).
Hepatic: Serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level > 1.5 x ULN; Aspartate aminotransferase (AST) ≤ 2.5 x ULN OR ≤ 5 x ULN, if liver metastases present and injection does not involve a visceral lesion; Alanine aminotransferase (ALT) ≤ 2.5 x ULN OR ≤ 5 x ULN, if liver metastases present and injection does not involve a visceral lesion
Coagulation: International normalization ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN, unless the subject is receiving anticoagulant therapy, in which case PT and partial thromboplastin time (PTT)/ activated PTT (aPTT) must be within therapeutic range of intended use of anticoagulants; PTT or aPTT ≤ 1.5 x ULN, unless the subject is receiving anticoagulant therapy as long as PT and PTT/aPTT is within therapeutic range of intended use of anticoagulants.
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Who cannot join

BRAF wild type tumor
M1b and M1c disease
Clinically active cerebral metastases, bony metastases, visceral metastases
Mucosal or ocular primary disease
Known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids >10 mg/day of prednisone or equivalent. The exception does not include carcinomatosus meningitis which is excluded regardless of clinical stability.
History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

Show all 32Show fewer

Evidence of clinically significant immunosuppression such as the following:
Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease.
Concurrent opportunistic infection.
Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 7 days prior to enrollment.
Active herpetic skin lesions or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use.
Previous treatment with talimogene laherparepvec or any other oncolytic virus.
Previous treatment with a BRAF or MEK inhibitor
Prior therapy with tumor vaccine.
Received live vaccine within 28 days prior to enrollment.
Prior immunosuppressive, chemotherapy, radiotherapy (in which the field encompassed a planned injection site), biological cancer therapy, or major surgery within 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment. Adjuvant hormonal therapy is allowed if appropriate for planned study.
Prior radiotherapy in which the field does not overlap the injection sites or non-immunosuppressive targeted therapy within 14 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 14 days prior to enrollment
Currently receiving treatment with another investigational device or drug study, or < 28 days since ending treatment with another investigational device or drug study(s).
Other investigational procedures while participating in this study are excluded.
Known to have acute or chronic active hepatitis B infection.
Known to have acute or chronic active hepatitis C infection.
Known to have human immunodeficiency virus (HIV) infection.
History of other malignancy within the past 5 years with the following exceptions:
Adequately treated non melanoma skin cancer without evidence of disease at the time of enrollment
Adequately treated cervical carcinoma in situ without evidence of disease at the time of enrollment
Adequately treated breast ductal carcinoma in situ without evidence of disease at the time of enrollment
Prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of enrollment.
Subject has known sensitivity to talimogene laherparepvec or any of its components to be administered during dosing.
Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec.
Sexually active subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with talimogene laherparepvec.
Subjects who are unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV-1 induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or infants under the age of 3 months, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec.

Trial locations and contacts

1 site in 1 country.

United States1 site

TriHealth Cancer Institute - Kenwood
Cincinnati, Ohio, 45236

Other trials in United States

About this study

Official title: Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma: A Pilot Study

Read the detailed description

This is a prospective, non-randomized, open-label, single-center interventional study looking at the response rate when using talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor in neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma. For this pilot study, a sample size of 20 participants, over 18 years of age will be included.

Conditions: Melanoma (Skin), Melanoma Stage IIIb-IVM1a, Metastasis Skin, Tumor Skin, BRAF Gene Mutation
Being tested: Talimogene laherparepvec (T-Vec), Dabrafenib (BRAF Inhibitor), Trametinib (MEK Inhibitor)
Keywords: T-VEC, BRAF/MEK inhibition, Melanoma, Nodal metastasis, Neoadjuvant treatment, BRAF mutant
Medical subject headings: Melanoma, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Talimogene laherparepvec (T-Vec)Drug
Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection
Dabrafenib (BRAF Inhibitor)Drug
Dabrafenib (BRAF Inhibitor) 150 mg by mouth twice a day
Trametinib (MEK Inhibitor)Drug
Trametinib (MEK Inhibitor) 2 mg by mouth once a day

Study groups in NCT03972046
Study group	Role	What they receive
T-Vec + BRAF/MEK	Experimental	Participants will begin taking the following 3 medications: BRAF Inhibitor dabrafenib 150 mg by mouth twice a day; MEK inhibitor trametinib 2 mg by mouth once a day; Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection (Dose #1: 10^6 PFU/mL; Dose #2: 10^8 PFU/mL 21 (+3) days after first dose; Subsequent doses: 10^8 PFU/mL every 14 (+/-3) days). Dosing to continue for at least 3 months, or up to 6 months if no plateau in response. May stop earlier than 3 months at physician discretion depending on side effects and response. Ultrasound of tumor nodal basin(s) monthly. Labs every 4 weeks: CBC with differential, CMP, LDH CT of chest/abdomen/pelvis every 3 months. PET CT or brain MRI as needed at discretion of the investigator. Manual tumor measurement in office prior to each injection. Receives: Drug: Talimogene laherparepvec (T-Vec); Drug: Dabrafenib (BRAF Inhibitor); Drug: Trametinib (MEK Inhibitor)

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of recurrence-free survival
Measured: 1 year

Secondary outcomes (17)

Rate of melanoma specific survival
Measured: 1 year
Rate of melanoma specific survival
Measured: 2 years
Rate of melanoma specific survival
Measured: 3 years
Rate of distant metastatic free survival
Measured: 1 year
Rate of distant metastatic free survival
Measured: 2 years
Rate of distant metastatic free survival
Measured: 3 years
Tumor response rate to therapy according to RECIST criteria
Measured: 3 months
Tumor response rate to therapy according to RECIST criteria
Measured: 6 months
Rate of pathological response in the surgical specimen
Measured: 3 months
Rate of pathological response in the surgical specimen
Measured: 6 months
Incidence of all adverse events (AEs)
includes treatment-related AEs, serious AEs, and fatal AEs
Measured: 1 month
Incidence of all adverse events (AEs)
includes treatment-related AEs, serious AEs, and fatal AEs
Measured: 2 months
Incidence of all adverse events (AEs)
includes treatment-related AEs, serious AEs, and fatal AEs
Measured: 3 months
Incidence of all adverse events (AEs)
includes treatment-related AEs, serious AEs, and fatal AEs
Measured: 4 months
Incidence of all adverse events (AEs)
includes treatment-related AEs, serious AEs, and fatal AEs
Measured: 5 months
Incidence of all adverse events (AEs)
includes treatment-related AEs, serious AEs, and fatal AEs
Measured: 6 months
Incidence of all adverse events (AEs)
includes treatment-related AEs, serious AEs, and fatal AEs
Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 20193 Feb 2020

First posted3 Jun 2019
Study start24 Jun 2019
Primary completion3 Feb 2020
Study completion3 Feb 2020

Why it stopped: Principal investigator leaving study site; no replacement PI will be sought

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Patients, aged 18+, seen at the TriHealth Cancer Institute and/or TriHealth Surgical Institute with a palpable regional melanoma metastasis at the time of initial presentation or with regional recurrence and tumors with a BRAF mutation will be considered for participation in this study.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03972046
Sponsor's protocol ID: 17-086
Other IDs: 20177504
Status last verified: Feb 2020
First submitted: 31 May 2019
Last updated: 19 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Flaherty KT, Infante JR, Daud A, Gonzalez R, Kefford RF, Sosman J, Hamid O, Schuchter L, Cebon J, Ibrahim N, Kudchadkar R, Burris HA 3rd, Falchook G, Algazi A, Lewis K, Long GV, Puzanov I, Lebowitz P, Singh A, Little S, Sun P, Allred A, Ouellet D, Kim KB, Patel K, Weber J. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med. 2012 Nov 1;367(18):1694-703. doi: 10.1056/NEJMoa1210093. Epub 2012 Sep 29.
PubMed 23020132
Andtbacka RH, Ross M, Puzanov I, Milhem M, Collichio F, Delman KA, Amatruda T, Zager JS, Cranmer L, Hsueh E, Chen L, Shilkrut M, Kaufman HL. Patterns of Clinical Response with Talimogene Laherparepvec (T-VEC) in Patients with Melanoma Treated in the OPTiM Phase III Clinical Trial. Ann Surg Oncol. 2016 Dec;23(13):4169-4177. doi: 10.1245/s10434-016-5286-0. Epub 2016 Jun 24.
PubMed 27342831
Andtbacka RH, Kaufman HL, Collichio F, Amatruda T, Senzer N, Chesney J, Delman KA, Spitler LE, Puzanov I, Agarwala SS, Milhem M, Cranmer L, Curti B, Lewis K, Ross M, Guthrie T, Linette GP, Daniels GA, Harrington K, Middleton MR, Miller WH Jr, Zager JS, Ye Y, Yao B, Li A, Doleman S, VanderWalde A, Gansert J, Coffin RS. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015 Sep 1;33(25):2780-8. doi: 10.1200/JCO.2014.58.3377. Epub 2015 May 26.
PubMed 26014293
Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.
PubMed 28055103
Coit DG, Thompson JA, Algazi A, Andtbacka R, Bichakjian CK, Carson WE 3rd, Daniels GA, DiMaio D, Ernstoff M, Fields RC, Fleming MD, Gonzalez R, Guild V, Halpern AC, Hodi FS Jr, Joseph RW, Lange JR, Martini MC, Materin MA, Olszanski AJ, Ross MI, Salama AK, Skitzki J, Sosman J, Swetter SM, Tanabe KK, Torres-Roca JF, Trisal V, Urist MM, McMillian N, Engh A. Melanoma, Version 2.2016, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2016 Apr;14(4):450-73. doi: 10.6004/jnccn.2016.0051.
PubMed 27059193
Thiam A, Zhao Z, Quinn C, Barber B. Years of life lost due to metastatic melanoma in 12 countries. J Med Econ. 2016;19(3):259-64. doi: 10.3111/13696998.2015.1115764. Epub 2015 Nov 25.
PubMed 26531249
Solit DB, Rosen N. Resistance to BRAF inhibition in melanomas. N Engl J Med. 2011 Feb 24;364(8):772-4. doi: 10.1056/NEJMcibr1013704. No abstract available.
PubMed 21345109
Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, Rutkowski P, Blank CU, Miller WH Jr, Kaempgen E, Martin-Algarra S, Karaszewska B, Mauch C, Chiarion-Sileni V, Martin AM, Swann S, Haney P, Mirakhur B, Guckert ME, Goodman V, Chapman PB. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012 Jul 28;380(9839):358-65. doi: 10.1016/S0140-6736(12)60868-X. Epub 2012 Jun 25.
PubMed 22735384
Johnson AS, Crandall H, Dahlman K, Kelley MC. Preliminary results from a prospective trial of preoperative combined BRAF and MEK-targeted therapy in advanced BRAF mutation-positive melanoma. J Am Coll Surg. 2015 Apr;220(4):581-93.e1. doi: 10.1016/j.jamcollsurg.2014.12.057. Epub 2015 Jan 30.
PubMed 25797743
Grigg C, Blake Z, Gartrell R, Sacher A, Taback B, Saenger Y. Talimogene laherparepvec (T-Vec) for the treatment of melanoma and other cancers. Semin Oncol. 2016 Dec;43(6):638-646. doi: 10.1053/j.seminoncol.2016.10.005. Epub 2016 Oct 27.
PubMed 28061981

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma: A Pilot Study
ClinicalTrials.gov ID: NCT03972046
Acronym / sponsor ID: 17-086
Conditions: Melanoma (Skin), Melanoma Stage IIIb-IVM1a, Metastasis Skin, Tumor Skin, BRAF Gene Mutation
Keywords: T-VEC, BRAF/MEK inhibition, Melanoma, Nodal metastasis, Neoadjuvant treatment, BRAF mutant
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Principal investigator leaving study site; no replacement PI will be sought
Enrolment: 0 participants (actual)
Lead sponsor: TriHealth Inc.University, hospital or other
Collaborators: TriHealth Cancer Institute, TriHealth Surgical Institute, TriHealth Ultrasound Department, Bethesda North TriHealth Hospital, Good Samaritan TriHealth Hospital
Study start: 24 Jun 2019 (actual)
Primary completion: 3 Feb 2020 (actual)
Study completion: 3 Feb 2020 (actual)
First posted: 3 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Patients, aged 18+, seen at the TriHealth Cancer Institute and/or TriHealth Surgical Institute with a palpable regional melanoma metastasis at the time of initial presentation or with regional recurrence and tumors with a BRAF mutation will be considered for participation in this study.

Arm	Type	Receives
T-Vec + BRAF/MEK	Experimental	Drug: Talimogene laherparepvec (T-Vec), Drug: Dabrafenib (BRAF Inhibitor), Drug: Trametinib (MEK Inhibitor)Participants will begin taking the following 3 medications: BRAF Inhibitor dabrafenib 150 mg by mouth twice a day; MEK inhibitor trametinib 2 mg by mouth once a day; Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection (Dose #1: 10^6 PFU/mL; Dose #2: 10^8 PFU/mL 21 (+3) days after first dose; Subsequent doses: 10^8 PFU/mL every 14 (+/-3) days). Dosing to continue for at least 3 months, or up to 6 months if no plateau in response. May stop earlier than 3 months at physician discretion depending on side effects and response. Ultrasound of tumor nodal basin(s) monthly. Labs every 4 weeks: CBC with differential, CMP, LDH CT of chest/abdomen/pelvis every 3 months. PET CT or brain MRI as needed at discretion of the investigator. Manual tumor measurement in office prior to each injection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Age ≥ 18
Malignant melanoma Stage IIIb-IVM1a patients.
Primary or recurrent disease.
Cutaneous primary melanoma or unknown primary.
Measurable disease as evidenced by:

Key exclusion criteria (32 listed)

BRAF wild type tumor
M1b and M1c disease
Clinically active cerebral metastases, bony metastases, visceral metastases
Mucosal or ocular primary disease
Known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids >10 mg/day of prednisone or equivalent. The exception does not include carcinomatosus meningitis which is excluded regardless of clinical stability.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Talimogene laherparepvec (T-Vec)Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection	Drug	T-Vec + BRAF/MEK
Dabrafenib (BRAF Inhibitor)Dabrafenib (BRAF Inhibitor) 150 mg by mouth twice a day	Drug	T-Vec + BRAF/MEK
Trametinib (MEK Inhibitor)Trametinib (MEK Inhibitor) 2 mg by mouth once a day	Drug	T-Vec + BRAF/MEK

Primary outcome

Rate of recurrence-free survival
Time frame: 1 year

17 secondary outcomes

Rate of melanoma specific survival
Time frame: 1 year
Rate of melanoma specific survival
Time frame: 2 years
Rate of melanoma specific survival
Time frame: 3 years
Rate of distant metastatic free survival
Time frame: 1 year
Rate of distant metastatic free survival
Time frame: 2 years
Rate of distant metastatic free survival
Time frame: 3 years
Tumor response rate to therapy according to RECIST criteria
Time frame: 3 months
Tumor response rate to therapy according to RECIST criteria
Time frame: 6 months
Rate of pathological response in the surgical specimen
Time frame: 3 months
Rate of pathological response in the surgical specimen
Time frame: 6 months
Incidence of all adverse events (AEs)
Time frame: 1 month
Incidence of all adverse events (AEs)
Time frame: 2 months
Incidence of all adverse events (AEs)
Time frame: 3 months
Incidence of all adverse events (AEs)
Time frame: 4 months
Incidence of all adverse events (AEs)
Time frame: 5 months
Incidence of all adverse events (AEs)
Time frame: 6 months
Incidence of all adverse events (AEs)
Time frame: 7 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Background: PubMed 23020132Flaherty KT, Infante JR, Daud A, Gonzalez R, Kefford RF, Sosman J, Hamid O, Schuchter L, Cebon J, Ibrahim N, Kudchadkar R, Burris HA 3rd, Falchook G, Algazi A, Lewis K, Long GV, Puzanov I, Lebowitz P, Singh A, Little S, Sun P, Allred A, Ouellet D, Kim KB, Patel K, Weber J. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med. 2012 Nov 1;367(18):1694-703. doi: 10.1056/NEJMoa1210093. Epub 2012 Sep 29.
Background: PubMed 27342831Andtbacka RH, Ross M, Puzanov I, Milhem M, Collichio F, Delman KA, Amatruda T, Zager JS, Cranmer L, Hsueh E, Chen L, Shilkrut M, Kaufman HL. Patterns of Clinical Response with Talimogene Laherparepvec (T-VEC) in Patients with Melanoma Treated in the OPTiM Phase III Clinical Trial. Ann Surg Oncol. 2016 Dec;23(13):4169-4177. doi: 10.1245/s10434-016-5286-0. Epub 2016 Jun 24.
Background: PubMed 26014293Andtbacka RH, Kaufman HL, Collichio F, Amatruda T, Senzer N, Chesney J, Delman KA, Spitler LE, Puzanov I, Agarwala SS, Milhem M, Cranmer L, Curti B, Lewis K, Ross M, Guthrie T, Linette GP, Daniels GA, Harrington K, Middleton MR, Miller WH Jr, Zager JS, Ye Y, Yao B, Li A, Doleman S, VanderWalde A, Gansert J, Coffin RS. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015 Sep 1;33(25):2780-8. doi: 10.1200/JCO.2014.58.3377. Epub 2015 May 26.
Background: PubMed 28055103Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.
Background: PubMed 27059193Coit DG, Thompson JA, Algazi A, Andtbacka R, Bichakjian CK, Carson WE 3rd, Daniels GA, DiMaio D, Ernstoff M, Fields RC, Fleming MD, Gonzalez R, Guild V, Halpern AC, Hodi FS Jr, Joseph RW, Lange JR, Martini MC, Materin MA, Olszanski AJ, Ross MI, Salama AK, Skitzki J, Sosman J, Swetter SM, Tanabe KK, Torres-Roca JF, Trisal V, Urist MM, McMillian N, Engh A. Melanoma, Version 2.2016, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2016 Apr;14(4):450-73. doi: 10.6004/jnccn.2016.0051.
Background: PubMed 26531249Thiam A, Zhao Z, Quinn C, Barber B. Years of life lost due to metastatic melanoma in 12 countries. J Med Econ. 2016;19(3):259-64. doi: 10.3111/13696998.2015.1115764. Epub 2015 Nov 25.
Background: PubMed 21345109Solit DB, Rosen N. Resistance to BRAF inhibition in melanomas. N Engl J Med. 2011 Feb 24;364(8):772-4. doi: 10.1056/NEJMcibr1013704. No abstract available.
Background: PubMed 22735384Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, Rutkowski P, Blank CU, Miller WH Jr, Kaempgen E, Martin-Algarra S, Karaszewska B, Mauch C, Chiarion-Sileni V, Martin AM, Swann S, Haney P, Mirakhur B, Guckert ME, Goodman V, Chapman PB. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012 Jul 28;380(9839):358-65. doi: 10.1016/S0140-6736(12)60868-X. Epub 2012 Jun 25.
Background: PubMed 25797743Johnson AS, Crandall H, Dahlman K, Kelley MC. Preliminary results from a prospective trial of preoperative combined BRAF and MEK-targeted therapy in advanced BRAF mutation-positive melanoma. J Am Coll Surg. 2015 Apr;220(4):581-93.e1. doi: 10.1016/j.jamcollsurg.2014.12.057. Epub 2015 Jan 30.
Background: PubMed 28061981Grigg C, Blake Z, Gartrell R, Sacher A, Taback B, Saenger Y. Talimogene laherparepvec (T-Vec) for the treatment of melanoma and other cancers. Semin Oncol. 2016 Dec;43(6):638-646. doi: 10.1053/j.seminoncol.2016.10.005. Epub 2016 Oct 27.
Individual participant dataSharing planned: No

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Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of recurrence-free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03972046, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.