MelanomaPhase 2PORTSIDENCT05926960
A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma
A Phase 2 study testing encorafenib, binimetinib and pembrolizumab in people with Melanoma, run by Pfizer at 24 sites in 5 countries.
Trial summary
The purpose of this study is to learn about the effects of 3 study medicines (encorafenib, binimetinib, pembrolizumab) compared to 2 study medicines (ipilimumab and nivolumab) given for the treatment of melanoma. Melanoma is a type of cancer that starts in the cells that give color to your skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- encorafenib, binimetinib and pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 13 Jun 2023to 2 Feb 2026
- 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
- Male or female participants ≥18 years of age at the time of informed consent.
- Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition.
- Documented evidence of a BRAF V600E or V600K mutation.
- Availability of adequate tumor tissue (archival or newly obtained; block or slides) to submit to the sponsor central laboratory(ies) during the screening period for central biomarker analyses .
- Must have received only 1 prior line of systemic therapy for melanoma (either adjuvant therapy or first-line anti-PD-1 monotherapy (ie, nivolumab or pembrolizumab)
- Must have anti-PD-1 resistant disease (primary or secondary) with confirmed disease progression per RECIST v1.1 either during or after receipt of an approved anti-PD-1 monotherapy (ie, nivolumab or pembrolizumab) for melanoma, defined according to the SITC Immunotherapy Resistance Taskforce (Kluger et al, 2020).
- Have at least one measurable lesion per RECIST v1.1.
- ECOG PS of 0-1, and adequate organ and cardiac function, including LVEF ≥50% by cardiac imaging.
Who cannot join
- Mucosal or ocular melanoma.
- Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment with chronic systemic steroid therapy or any other form of immunosuppressive therapy within the past 2 years.
- Clinically significant cardiovascular diseases.
- History of thromboembolic or cerebrovascular events ≤12 weeks prior to randomization.
- History or current evidence of RVO or current risk factors for RVO.
- Concurrent neuromuscular disorder that is associated with the potential of elevated CK.
Show all 11Show fewer
- Active bacterial, fungal, or viral infection requiring systemic therapeutic treatment within 2 weeks prior to randomization.
- Current non-infectious pneumonitis/interstitial lung disease or history of noninfectious pneumonitis/interstitial lung disease requiring steroids.
- Prior or current symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases.
- Participants who permanently discontinued prior anti-PD-1 therapy due to toxicity or will be unable to tolerate combination therapy based on investigator judgement are excluded.
- Prior treatment with ipilimumab; prior combined immunotherapy blockade with anti-PD-1/L-1; prior treatment with a BRAFi and/or MEKi; or previous administration of an investigational anti-cancer agent for the adjuvant or first-line treatment of melanoma prior to randomization.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
Italy8 sites
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, 10060
Istituto Europeo di Oncologia IRCCS
Milan, 20141
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131
Istituto Oncologico Veneto IRCCS
Padova, Veneto, 35128
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, 90127
AO Santa Maria della Misericordia
Perugia, Umbria, 06132
Istituto Nazionale Tumori Regina Elena
Rome, ROMA, 00144
Azienda Ospedaliero Universitaria Senese
Siena, Tuscany, 53100
Spain7 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona], 08916
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalunya [cataluña], 08908
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital General Universitario de Valencia
Valencia, Valenciana, Comunitat, 46014
Hospital Universitario Miguel Servet
Zaragoza, 50009
Germany6 sites
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, 55131
Fachklinik Hornheide
Münster, North Rhine-Westphalia, 48157
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Slovakia2 sites
Narodny onkologicky ustav
Bratislava, 833 10
Neovizia, s.r.o.
Bratislava, 85101
About this study
Official title: A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS NIVOLUMAB AND IPILIMUMAB IN PARTICIPANTS WITH BRAF V600E/K MUTATION-POSITIVE MELANOMA WHO PROGRESSED DURING OR AFTER PRIOR TREATMENT WITH ANTI-PD-1 THERAPY
The purpose of this study is to learn about the effects of 3 study medicines (encorafenib, binimetinib, pembrolizumab) compared to 2 study medicines (ipilimumab and nivolumab) given for the treatment of melanoma.
Melanoma is a type of cancer that starts in the cells that give color to your skin.
Read more
The study is seeking participants who:
- have advanced or metastatic melanoma (has spread to other parts of the body);
- have a certain abnormal gene called "BRAF".
- have taken nivolumab or pembrolizumab treatment before this study.
Participants will either receive:
- pembrolizumab given by intravenous infusion (directly into a vein) every 3 weeks at the study clinic. Participants will also receive encorafenib and binimetinib by mouth every day at home,
- or will receive ipilimumab and nivolumab given by intravenous infusion (directly into a vein) every 3 weeks at the study clinic 4 times. This will be followed by nivolumab given by intravenous infusion every 4 weeks at the study clinic.
Both pembrolizumab and nivolumab will be given for a maximum of around 2 years. However, there is no time limit for encorafenib and binimetinib treatment.
The study team will see how each participant is doing after receiving the study treatments during regular visits to the study clinic.
Read the detailed description
The purpose of the study is to compare the efficacy of a triplet therapy (encorafenib, binimetinib, pembrolizumab) versus a doublet/control therapy (nivolumab and ipilimumab). Participants will have metastatic or unresectable locally advanced BRAF V600E/K-mutant melanoma, which progressed during or after prior treatment in the adjuvant or first-line metastatic setting, with an approved anti-PD-1 monotherapy (pembrolizumab or nivolumab),
Approximately 150 participants will be randomized in a 1:1 ratio to the triplet or the doublet/control therapy (75 participants in each arm). Randomization will be stratified by baseline serum LDH level, and by type of PD-1 resistance.
- Conditions
- Melanoma
- Being tested
- encorafenib, binimetinib, pembrolizumab, ipilimumab, nivolumab
- Keywords
- BRAF, BRAF V600E/K melanoma, metastatic melanoma, advanced melanoma, skin cancer, portside
- 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.
encorafenibDrug
Also called BRAFTOVI
encorafenib
binimetinibDrug
Also called MEKTOVI
binimetinib
pembrolizumabDrug
Also called KEYTRUDA®
pembrolizumab
ipilimumabDrug
Also called YERVOY
ipilimumab
nivolumabDrug
Also called OPDIVO
nivolumab
| Study group | Role | What they receive |
|---|---|---|
| Triplet | Experimental | encorafenib and binimetinib in combination with pembrolizumab Receives: Drug: encorafenib; Drug: binimetinib; Drug: pembrolizumab |
| Doublet | Active comparator | ipilimumab and nivolumab Receives: Drug: ipilimumab; Drug: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) is defined as the proportion of participants in each treatment arm with a confirmed best overall response of either Complete Response (CR) or Partial Response (PR), as determined by investigator assessment per RECIST v1.1
Measured: Time from the date of randomization to the earliest date disease progression, or start of subsequent anticancer therapy, or death due to any cause (assessed up to approximately 48 months).
Secondary outcomes (10)
Progression Free Survival in each treatment arm
Measured: Time from the date of randomization to the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first (assessed up to approximately 48 months)
Overall Survival in each treatment arm
Measured: Time from date of randomization to the date of death due to any cause or the last known alive date (assessed up to approximately 48 months)
Duration of Response (CR or PR) in each treatment arm
Measured: Time from the date of the first documented response (CR or PR) to the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause (assessed up to approximately 48 months)
Disease Control Rate (proportion of participants with a confirmed best overall response of CR, PR or SD) in each treatment arm
Measured: Time from the date of randomization to the earliest date of disease progression, or start of subsequent anticancer therapy (assessed up to approximately 48 months)
Time to Response (CR or PR)
Measured: Time from the date of randomization to the date of first documented response (CR or PR), as determined by investigator assessment per RECIST v1.1 (assessed up to approximately 48 months)
Progression Free Survival 2 in each treatment arm
Measured: Time from date of randomization to date of discontinuation of next-line treatment after 1st disease progression, 2nd disease progression after initiation of next line treatment, or death due to any cause (assessed up to approximately 48 months)
Incidence and severity of Adverse Events (AEs) and changes in clinical laboratory parameters, vital signs, and cardiac assessments.
Number of participants with treatment emergent Adverse Events as as assessed per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.03).
Measured: Time from first dose of study intervention through 28 days after the last dose of study intervention
Patient Reported Outcomes using EORTC QLQ-C30 questionnaires in each treatment arm
EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 includes 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/Quality of Life scale
Measured: Change from Baseline until Progressive Disease, death, withdrawal of consent, lost to follow-up, or end of study, whichever occurs first (assessed up to approximately 48 months)
Patient Reported Outcomes using EuroQOL EQ-5D-5L questionnaires in each treatment arm
The EQ-5D-5L is a standardized measure of health utility that provides a single index value of health status and contains 1 item for each of 5 dimensions of HRQoL (ie, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression).
Measured: Change from Baseline until Progressive Disease, death, withdrawal of consent, lost to follow-up, or end of study, whichever occurs first (assessed up to approximately 48 months)
BRAF V600E/K Variant Allele Frequency and/or overall mean Variant Allele Frequency from circulating tumour DNA analysis in each treatment arm
Measured: Change from baseline, Day 1 of Cycle 2 (after 3 weeks), and End of Treatment (assessed up to approximately 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start13 Jun 2023
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Why it stopped: Study terminated due to inability to recruit the target number of patients. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926960
- Sponsor's protocol ID
- C4221023
- Other IDs
- KEYNOTE PNC92; PORTSIDE, 2023-509471-17-00, MK-3475-C92, 2023
- Acronym
- PORTSIDE
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2023
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS NIVOLUMAB AND IPILIMUMAB IN PARTICIPANTS WITH BRAF V600E/K MUTATION-POSITIVE MELANOMA WHO PROGRESSED DURING OR AFTER PRIOR TREATMENT WITH ANTI-PD-1 THERAPY
- ClinicalTrials.gov ID
- NCT05926960
- Acronym / sponsor ID
- PORTSIDE / C4221023
- Conditions
- Melanoma
- Keywords
- BRAF, BRAF V600E/K melanoma, metastatic melanoma, advanced melanoma, skin cancer, portside
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to inability to recruit the target number of patients. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 3 Jul 2023 (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.
The purpose of this study is to learn about the effects of 3 study medicines (encorafenib, binimetinib, pembrolizumab) compared to 2 study medicines (ipilimumab and nivolumab) given for the treatment of melanoma.
Melanoma is a type of cancer that starts in the cells that give color to your skin.
The study is seeking participants who:
- have advanced or metastatic melanoma (has spread to other parts of the body);
- have a certain abnormal gene called "BRAF".
- have taken nivolumab or pembrolizumab treatment before this study.
Participants will either receive:
- pembrolizumab given by intravenous infusion (directly into a vein) every 3 weeks at the study clinic. Participants will also receive encorafenib and binimetinib by mouth every day at home,
- or will receive ipilimumab and nivolumab given by intravenous infusion (directly into a vein) every 3 weeks at the study clinic 4 times. This will be followed by nivolumab given by intravenous infusion every 4 weeks at the study clinic.
Both pembrolizumab and nivolumab will be given for a maximum of around 2 years. However, there is no time limit for encorafenib and binimetinib treatment.
The study team will see how each participant is doing after receiving the study treatments during regular visits to the study clinic.
Detailed description
The purpose of the study is to compare the efficacy of a triplet therapy (encorafenib, binimetinib, pembrolizumab) versus a doublet/control therapy (nivolumab and ipilimumab). Participants will have metastatic or unresectable locally advanced BRAF V600E/K-mutant melanoma, which progressed during or after prior treatment in the adjuvant or first-line metastatic setting, with an approved anti-PD-1 monotherapy (pembrolizumab or nivolumab),
Approximately 150 participants will be randomized in a 1:1 ratio to the triplet or the doublet/control therapy (75 participants in each arm). Randomization will be stratified by baseline serum LDH level, and by type of PD-1 resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triplet | Experimental | Drug: encorafenib, Drug: binimetinib, Drug: pembrolizumabencorafenib and binimetinib in combination with pembrolizumab |
| Doublet | Active comparator | Drug: ipilimumab, Drug: nivolumabipilimumab and nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female participants ≥18 years of age at the time of informed consent.
- Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition.
- Documented evidence of a BRAF V600E or V600K mutation.
- Availability of adequate tumor tissue (archival or newly obtained; block or slides) to submit to the sponsor central laboratory(ies) during the screening period for central biomarker analyses .
- Must have received only 1 prior line of systemic therapy for melanoma (either adjuvant therapy or first-line anti-PD-1 monotherapy (ie, nivolumab or pembrolizumab)
Key exclusion criteria (11 listed)
- Mucosal or ocular melanoma.
- Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment with chronic systemic steroid therapy or any other form of immunosuppressive therapy within the past 2 years.
- Clinically significant cardiovascular diseases.
- History of thromboembolic or cerebrovascular events ≤12 weeks prior to randomization.
- History or current evidence of RVO or current risk factors for RVO.
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: BRAFTOVIencorafenib | Drug | Triplet |
| binimetinibAlso: MEKTOVIbinimetinib | Drug | Triplet |
| pembrolizumabAlso: KEYTRUDA®pembrolizumab | Drug | Triplet |
| ipilimumabAlso: YERVOYipilimumab | Drug | Doublet |
| nivolumabAlso: OPDIVOnivolumab | Drug | Doublet |
Primary outcome
Objective Response Rate (ORR) is defined as the proportion of participants in each treatment arm with a confirmed best overall response of either Complete Response (CR) or Partial Response (PR), as determined by investigator assessment per RECIST v1.1
Time frame: Time from the date of randomization to the earliest date disease progression, or start of subsequent anticancer therapy, or death due to any cause (assessed up to approximately 48 months).
10 secondary outcomes
Progression Free Survival in each treatment arm
Time frame: Time from the date of randomization to the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first (assessed up to approximately 48 months)
Overall Survival in each treatment arm
Time frame: Time from date of randomization to the date of death due to any cause or the last known alive date (assessed up to approximately 48 months)
Duration of Response (CR or PR) in each treatment arm
Time frame: Time from the date of the first documented response (CR or PR) to the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause (assessed up to approximately 48 months)
Disease Control Rate (proportion of participants with a confirmed best overall response of CR, PR or SD) in each treatment arm
Time frame: Time from the date of randomization to the earliest date of disease progression, or start of subsequent anticancer therapy (assessed up to approximately 48 months)
Time to Response (CR or PR)
Time frame: Time from the date of randomization to the date of first documented response (CR or PR), as determined by investigator assessment per RECIST v1.1 (assessed up to approximately 48 months)
Progression Free Survival 2 in each treatment arm
Time frame: Time from date of randomization to date of discontinuation of next-line treatment after 1st disease progression, 2nd disease progression after initiation of next line treatment, or death due to any cause (assessed up to approximately 48 months)
Incidence and severity of Adverse Events (AEs) and changes in clinical laboratory parameters, vital signs, and cardiac assessments.
Time frame: Time from first dose of study intervention through 28 days after the last dose of study intervention
Patient Reported Outcomes using EORTC QLQ-C30 questionnaires in each treatment arm
Time frame: Change from Baseline until Progressive Disease, death, withdrawal of consent, lost to follow-up, or end of study, whichever occurs first (assessed up to approximately 48 months)
Patient Reported Outcomes using EuroQOL EQ-5D-5L questionnaires in each treatment arm
Time frame: Change from Baseline until Progressive Disease, death, withdrawal of consent, lost to follow-up, or end of study, whichever occurs first (assessed up to approximately 48 months)
BRAF V600E/K Variant Allele Frequency and/or overall mean Variant Allele Frequency from circulating tumour DNA analysis in each treatment arm
Time frame: Change from baseline, Day 1 of Cycle 2 (after 3 weeks), and End of Treatment (assessed up to approximately 48 months)
Results and safety
The study was stopped early (reason given: Study terminated due to inability to recruit the target number of patients. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing encorafenib, binimetinib and pembrolizumab in people with Melanoma, run by Pfizer at 24 sites in 5 countries.
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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy, Spain, Germany, Slovakia, Poland. 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 stopped early (reason given: Study terminated due to inability to recruit the target number of patients. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.). Results are not available in the source record.
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?
Objective Response Rate (ORR) is defined as the proportion of participants in each treatment arm with a confirmed best overall response of either Complete Response (CR) or Partial Response (PR), as determined by investigator assessment per RECIST v1.1 (time frame: Time from the date of randomization to the earliest date disease progression, or start of subsequent anticancer therapy, or death due to any cause (assessed up to approximately 48 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2026.