Malignant MelanomaPhase 1/2IMMU-TARGETNCT02902042
Encorafenib + Binimetinib + Pembrolizumab in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
A Phase 1/2 study testing Encorafenib, Binimetinib and Pembrolizumab in people with Malignant Melanoma, run by Prof. Dr. med. Dirk Schadendorf at 11 sites in Germany.
Trial summary
This study will investigate the influence of maintenance therapy on progression-free survival (PFS) and overall survival (OS) after combination therapy with BRAF/MEK (MAP-ERK kinase) inhibitors and PD-1 antibody pembrolizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Encorafenib, Binimetinib and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 11 sitesGermany
- Study dates
- 24 Apr 2018to 30 Nov 2020
- Phase
- Phase 1/2
- 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
- Willing and able to provide written informed consent/assent for the trial.
- Being ≥ 18 years of age on day of signing informed consent.
- Histologically confirmed diagnosis of locally advanced, unresectable or metastatic melanoma AJCC (2017) Stage IIIB, IIIC, IIID or IV with no active brain metastasis. All known CNS lesions must have been only treated with stereotactic therapy or surgery at least 4 weeks prior to the first dose of trial treatment AND they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline); there is no evidence of new or enlarging brain metastases, and the patient must not have used steroids in dosing exceeding 10 mg daily of prednisone equivalent for at least 3 weeks prior to trial treatment.
- Treatment naive patient for locally advanced unresectable or metastatic melanoma. Prior adjuvant or neoadjuvant systemic therapy is permitted (in stage II, III and IV with no evidence of disease) if all related adverse events have either returned to baseline or stabilized.
- Anti-PD-1, anti-CTLA-4, BRAF/MEK inhibitor therapy with at least 6 months between the last dose and date of recurrence.
- Interferon therapy and chemotherapy with the last dose at least 6 weeks prior to registration.
Show all 19Show fewer
- Radiotherapy with the last radiation at least 28 days prior to registration. Participants must have recovered from all radiation-related toxicities. Note: radiated lesions cannot be used as measurable lesions unless there is clear evidence of progression.
- Patients who are in follow-up period of a clinical trial in adjuvant setting may be enrolled.
- Measurable disease, i.e., present with at least one measurable lesion per RECIST, version 1.1, for the definition of a measureable lesion.
- Presence of BRAF mutation V600 in tumor tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion prior to enrollment.
- Performance status of 0 or 1 on the ECOG Performance Scale.
- Adequate organ function: ANC ≥1,500 /mcL, Platelets ≥100,000 / mcL, Hemoglobin ≥9 g/dL OR ≥5.6 mmol/L, Serum creatinine OR Measured or calculated CrCl ≤1.5 X ULN OR ≥50 mL/min for subject with creatinine levels > 1.5 X institutional ULN, Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN, AST and ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases.
- Adequate cardiac function:
- LVEF ≥ 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram
- Corrected QT (QTc) interval ≤ 480ms
- All treatment-related toxicities of prior adjuvant or neoadjuvant systemic therapy (except alopecia) must be ≤ Grade 1 according to the CTCAE version 4.03:
- Able to take oral medications.
- Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
- Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to CTFG starting with the first dose of study therapy during the course of this study and for at least 120 days after the last dose of study medication
Who cannot join
- Currently participating in or having participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy in dosing exceeding 10 mg daily of prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to study Day 1.
- Prior therapy (except if given as adjuvant or neoadjuvant therapy for melanoma) with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (except for interferon given as adjuvant or neoadjuvant therapy for melanoma).
- Prior therapy (except if given as adjuvant or neoadjuvant therapy for melanoma) with a BRAF inhibitor (including but not limited to vemurafenib, dabrafenib, encorafenib) and / or MEK inhibitor (including but not limited to trametinib, AZD6244, binimetinib, cobimetinib).
- Any previous anti-cancer treatment, extensive radiotherapy or investigational agent for locally advanced unresectable or metastatic melanoma.
- Known additional malignancy that is progressing or required active treatment within 3 years prior to the study.
Show all 26Show fewer
- Known active CNS metastases and/or carcinomatous meningitis.
- Presence of uveal melanoma.
- History of leptomeningeal metastases.
- History or current evidence of CSR or RVO or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled diabetes mellitus, history of hyperviscosity or hypercoagulability syndromes).
- History of retinal degenerative disease.
- History of allogeneic bone marrow transplantation or organ transplantation.
- History of Gilbert's syndrome.
- Uncontrolled arterial hypertension despite medical treatment.
- Patients who have neuromuscular disorders associated with elevated creatine kinase (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
- Impairment of gastrointestinal function or gastrointestinal disease (e.g. ulcerative disease, uncontrolled nausea, vomiting, malabsorption syndrome, small bowel resection).
- Evidence of interstitial lung disease or active, non-infectious pneumonitis or history of (non-infectious) pneumonitis that required steroids.
- Active infection requiring systemic therapy.
- Pregnancy or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit until up to 120 days after the last dose of trial treatment.
- Positive test for HIV.
- Positive test for Hep B or Hep C.
- Receiving a live vaccine within 30 days prior to the first dose of trial treatment.
- Known hypersensitivity reaction to any of the components of study treatment.
- Medical, psychiatric, cognitive or other conditions, including known alcohol or drug abuse that would not permit the subject to complete the study or sign informed consent.
- Patients taking non-topical medication known to be a strong inhibitor of CYP3A4.
- History of life-threatening toxicity related to prior immune therapy (e.g. anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) or kinase inhibition (e.g. BRAF and/or MEK inhibitor) except those that are unlikely to re-occur with standard countermeasures (e.g. hormone replacement after adrenal crisis).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Universitätsklinikum der RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
Klinikum Augsburg Süd
Augsburg, Bavaria, 86179
Städtisches Klinikum Dessau
Dessau, Saxony-Anhalt, 06847
University Hospital Essen, Department of Dermatology, Skin Cancer Center
Essen, North Rhine-Westphalia, 45122
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Vivantes Klinikum im Friedrichshain
Friedrichshain, State of Berlin, 10249
Universitätsklinikum Gießen und Marburg GmbH, Klinik für Dermatologie und Allergologie
Giessen, Hesse, 35392
HELIOS Klinikum Krefeld
Krefeld, North Rhine-Westphalia, 47805
Gesellschaft für Klinische Forschung Ludwigshafen mbH
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063
Klinikum rechts der Isar
München, Bavaria, 81675
Klinikum Nürnberg Nord
Nuremberg, Bavaria, 90419
About this study
Official title: A Randomized Phase I / II Open Label, Multicentre Study of Encorafenib Plus Binimetinib and PD-1 Antibody Pembrolizumab in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
This study will investigate the influence of maintenance therapy on progression-free survival (PFS) and overall survival (OS) after combination therapy with BRAF/MEK (MAP-ERK kinase) inhibitors and PD-1 antibody pembrolizumab.
In the safety phase I part the optimal dose of pembrolizumab in combination with BRAF inhibitor and MEK inhibitor and the safety of this three-drugs-combination regime will be determined.
In the randomized part 2 different maintenance therapies will be tested for toxicity and efficacy. Patients with disease control after 6 months of triple therapy will be randomized to receive 2 different maintenance therapies further on, either continuation of triple therapy or administration of pembrolizumab alone.
Read the detailed description
There is growing interest to understand the best strategies to use targeted therapies and novel immunotherapy for the treatment of advanced melanoma. This study will explore the combination of encorafenib plus binimetinib with the PD-1 antibody pembrolizumab in patients with BRAF mutant melanoma. Combination of two clinically effective approaches, targeting the mutant BRAF pathway by BRAF/MEK inhibition and modulating immunological checkpoint control by administration of a PD-1 antibody, should prolong PFS and OS even further. This study will investigate the influence of maintenance therapy on PFS and OS after triple therapy. Patients with disease control after 6 months of triple therapy will be randomized to receive 2 different maintenance therapies further on to investigate if administration of pembrolizumab only is sufficient for maintenance of disease control. For reasons of safety a phase I study is performed to determine the optimal dosing and schedule of the combination therapy (encorafenib, binimetinib, pembrolizumab).
In the phase II-part, patient will receive triple therapy with the doses defined in phase I for a 6 months induction period. Patients with complete or partial response or stable disease after the 6 months period will be randomized for maintenance therapy:
Arm A: Therapy as in induction period. Arm B: Therapy with pembrolizumab only with a dose of 200 mg every 3 weeks.
- Conditions
- Malignant Melanoma
- Being tested
- Encorafenib, Binimetinib, Pembrolizumab, Pembrolizumab alone
- Keywords
- Unresectable or metastatic BRAF V600 mutant melanoma, Encorafenib, binimetinib, pembrolizumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EncorafenibDrug
Also called Braftovi
Dose determined in phase I. Start dose: 450 mg qd
BinimetinibDrug
Also called Mektovi
Dose determined in phase I. Start dose: 45 mg bid
PembrolizumabDrug
Also called Keytruda
Dose determined in phase I. Start dose: 200 mg q3w
Pembrolizumab aloneDrug
Also called Keytruda
200 mg q3w
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Triple therapy | Experimental | Encorafenib, binimetinib and pembrolizumab. Doses as determined in phase I Receives: Drug: Encorafenib; Drug: Binimetinib; Drug: Pembrolizumab |
| Arm B: Pembrolizumab alone | Experimental | Pembrolizumab with a dose of 200 mg every 3 weeks. Receives: Drug: Pembrolizumab alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of the triple combination treatment]
Dose limiting toxicities (DLT) will be determined within 42 days of therapy start (first pembrolizumab injection) and are defined as all ≥ grade 4 hematological toxicities and certain non-hematological toxicities ≥ CTCAE grade 3.
Measured: 42 days
Phase II: Progression-free survival (PFS)
Time from administration of first study drug to the date of first documented progression (according Recist criteria version 1.1) or death due to any cause, whichever occurs first.
Measured: 24 months
Phase II: PFS rate at 12 months
Rate of patients with PFS after 12 months of therapy
Measured: 12 months
Phase II: PFS rate at 18 months
Rate of patients with PFS after 18 months of therapy
Measured: 18 months
Phase II: PFS rate at 24 months
Number of patients with PFS after 24 months of therapy
Measured: 24 months
Secondary outcomes (5)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
All adverse events (AEs) / serious adverse events (SAEs) NCI CTCEA (Common Terminology Criteria for Adverse Events) Grade ≥ 3
Measured: 24 months
Objective response rate
Number of patients with complete response (CR), partial response (PR) and stable disease (SD) as best response.
Measured: 24 months
Overall survival time
Time from the date of first administration of study drug to the date of death due to any cause.
Measured: 24 months
1-year survival rate
Number of patients alive in the time period from date of first administration of study drug until 1 year after date of first administration
Measured: 12 months
2-year survival rate
Number of patients alive in the time period from date of first administration of study drug until 2 years after date of first administration
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start24 Apr 2018
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Dirk Schadendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Dirk Schadendorf, University Hospital, Essen
- Investigators
- Dirk Schadendorf, Prof. Dr., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902042
- Sponsor's protocol ID
- IST-818-201X
- Acronym
- IMMU-TARGET
- Status last verified
- Feb 2021
- First submitted
- 12 Sep 2016
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zimmer L, Livingstone E, Krackhardt A, Schultz ES, Goppner D, Assaf C, Trebing D, Stelter K, Windemuth-Kieselbach C, Ugurel S, Schadendorf D. Encorafenib, binimetinib plus pembrolizumab triplet therapy in patients with advanced BRAFV600 mutant melanoma: safety and tolerability results from the phase I IMMU-TARGET trial. Eur J Cancer. 2021 Nov;158:72-84. doi: 10.1016/j.ejca.2021.09.011. Epub 2021 Oct 13.
PubMed 34655839
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase I / II Open Label, Multicentre Study of Encorafenib Plus Binimetinib and PD-1 Antibody Pembrolizumab in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
- ClinicalTrials.gov ID
- NCT02902042
- Acronym / sponsor ID
- IMMU-TARGET / IST-818-201X
- Conditions
- Malignant Melanoma
- Keywords
- Unresectable or metastatic BRAF V600 mutant melanoma, Encorafenib, binimetinib, pembrolizumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Prof. Dr. med. Dirk SchadendorfUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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.
This study will investigate the influence of maintenance therapy on progression-free survival (PFS) and overall survival (OS) after combination therapy with BRAF/MEK (MAP-ERK kinase) inhibitors and PD-1 antibody pembrolizumab.
In the safety phase I part the optimal dose of pembrolizumab in combination with BRAF inhibitor and MEK inhibitor and the safety of this three-drugs-combination regime will be determined.
In the randomized part 2 different maintenance therapies will be tested for toxicity and efficacy. Patients with disease control after 6 months of triple therapy will be randomized to receive 2 different maintenance therapies further on, either continuation of triple therapy or administration of pembrolizumab alone.
Detailed description
There is growing interest to understand the best strategies to use targeted therapies and novel immunotherapy for the treatment of advanced melanoma. This study will explore the combination of encorafenib plus binimetinib with the PD-1 antibody pembrolizumab in patients with BRAF mutant melanoma. Combination of two clinically effective approaches, targeting the mutant BRAF pathway by BRAF/MEK inhibition and modulating immunological checkpoint control by administration of a PD-1 antibody, should prolong PFS and OS even further. This study will investigate the influence of maintenance therapy on PFS and OS after triple therapy. Patients with disease control after 6 months of triple therapy will be randomized to receive 2 different maintenance therapies further on to investigate if administration of pembrolizumab only is sufficient for maintenance of disease control. For reasons of safety a phase I study is performed to determine the optimal dosing and schedule of the combination therapy (encorafenib, binimetinib, pembrolizumab).
In the phase II-part, patient will receive triple therapy with the doses defined in phase I for a 6 months induction period. Patients with complete or partial response or stable disease after the 6 months period will be randomized for maintenance therapy:
Arm A: Therapy as in induction period. Arm B: Therapy with pembrolizumab only with a dose of 200 mg every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Triple therapy | Experimental | Drug: Encorafenib, Drug: Binimetinib, Drug: PembrolizumabEncorafenib, binimetinib and pembrolizumab. Doses as determined in phase I |
| Arm B: Pembrolizumab alone | Experimental | Drug: Pembrolizumab alonePembrolizumab with a dose of 200 mg every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Willing and able to provide written informed consent/assent for the trial.
- Being ≥ 18 years of age on day of signing informed consent.
- Histologically confirmed diagnosis of locally advanced, unresectable or metastatic melanoma AJCC (2017) Stage IIIB, IIIC, IIID or IV with no active brain metastasis. All known CNS lesions must have been only treated with stereotactic therapy or surgery at least 4 weeks prior to the first dose of trial treatment AND they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline); there is no evidence of new or enlarging brain metastases, and the patient must not have used steroids in dosing exceeding 10 mg daily of prednisone equivalent for at least 3 weeks prior to trial treatment.
- Treatment naive patient for locally advanced unresectable or metastatic melanoma. Prior adjuvant or neoadjuvant systemic therapy is permitted (in stage II, III and IV with no evidence of disease) if all related adverse events have either returned to baseline or stabilized.
- Interferon therapy and chemotherapy with the last dose at least 6 weeks prior to registration.
Key exclusion criteria (26 listed)
- Currently participating in or having participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy in dosing exceeding 10 mg daily of prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to study Day 1.
- Prior therapy (except if given as adjuvant or neoadjuvant therapy for melanoma) with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (except for interferon given as adjuvant or neoadjuvant therapy for melanoma).
- Prior therapy (except if given as adjuvant or neoadjuvant therapy for melanoma) with a BRAF inhibitor (including but not limited to vemurafenib, dabrafenib, encorafenib) and / or MEK inhibitor (including but not limited to trametinib, AZD6244, binimetinib, cobimetinib).
- Any previous anti-cancer treatment, extensive radiotherapy or investigational agent for locally advanced unresectable or metastatic melanoma.
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 |
|---|---|---|
| EncorafenibAlso: BraftoviDose determined in phase I. Start dose: 450 mg qd | Drug | Arm A: Triple therapy |
| BinimetinibAlso: MektoviDose determined in phase I. Start dose: 45 mg bid | Drug | Arm A: Triple therapy |
| PembrolizumabAlso: KeytrudaDose determined in phase I. Start dose: 200 mg q3w | Drug | Arm A: Triple therapy |
| Pembrolizumab aloneAlso: Keytruda200 mg q3w | Drug | Arm B: Pembrolizumab alone |
Primary outcome
Phase I: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of the triple combination treatment]
Time frame: 42 days
Dose limiting toxicities (DLT) will be determined within 42 days of therapy start (first pembrolizumab injection) and are defined as all ≥ grade 4 hematological toxicities and certain non-hematological toxicities ≥ CTCAE grade 3.
Phase II: Progression-free survival (PFS)
Time frame: 24 months
Time from administration of first study drug to the date of first documented progression (according Recist criteria version 1.1) or death due to any cause, whichever occurs first.
Phase II: PFS rate at 12 months
Time frame: 12 months
Rate of patients with PFS after 12 months of therapy
Phase II: PFS rate at 18 months
Time frame: 18 months
Rate of patients with PFS after 18 months of therapy
Phase II: PFS rate at 24 months
Time frame: 24 months
Number of patients with PFS after 24 months of therapy
5 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 24 months
Objective response rate
Time frame: 24 months
Overall survival time
Time frame: 24 months
1-year survival rate
Time frame: 12 months
2-year survival rate
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Derived from this study: PubMed 34655839Zimmer L, Livingstone E, Krackhardt A, Schultz ES, Goppner D, Assaf C, Trebing D, Stelter K, Windemuth-Kieselbach C, Ugurel S, Schadendorf D. Encorafenib, binimetinib plus pembrolizumab triplet therapy in patients with advanced BRAFV600 mutant melanoma: safety and tolerability results from the phase I IMMU-TARGET trial. Eur J Cancer. 2021 Nov;158:72-84. doi: 10.1016/j.ejca.2021.09.011. Epub 2021 Oct 13.
- Individual participant dataSharing planned: No
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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.
Dirk Schadendorf, Prof. Dr. principal investigator
University Hospital, Essen
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Encorafenib, Binimetinib and Pembrolizumab in people with Malignant Melanoma, run by Prof. Dr. med. Dirk Schadendorf at 11 sites in Germany.
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 26 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: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase I: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of the triple combination treatment] (time frame: 42 days). The study lists 5 primary outcomes in all. 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 NCT02902042, which also lists 1 linked publication.
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 16 Feb 2021.