Cutaneous Squamous Cell Carcinoma of the Head and NeckPhase 2DESQUAMATENCT05025813
Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma
A Phase 2 study testing Pembrolizumab in people with Cutaneous Squamous Cell Carcinoma of the Head and Neck and Head and Neck Cancer, run by Queensland Health at 3 sites in Australia.
Trial summary
Cutaneous Squamous Cell Carcinoma (cSCC) is typically associated with a high tumour mutation burden, with the majority caused by Ultraviolet (UV) exposure (Pickering et al., 2014). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma of the Head and Neck, Head and Neck Cancer
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesAustralia
- Study dates
- 28 Jun 2022to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed diagnosis of invasive cSCC that is locally advanced (Stage II-IV on AJCC 8th edition) assessed preoperatively as sufficiently high risk that they will warrant post-operatively RT (as recommended by MDT) who is a candidate for a complete resection.
- Note: Participants with tumors arising on cutaneous non-glabrous (hair-bearing) lip with extension onto vermillion (dry red lip) may be eligible after communication and approval from the principal investigator. Participants for whom the primary site is the nose may be eligible after communication and approval from the MDT if the primary site is skin, not nasal mucosa with outward extension to skin. Participants who have squamous cell parotid metastases and have been treated previously for cSCC are permitted. cSCC that has recurred in the same location after 2 or more surgical procedures are not eligible.
- Participants must have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days prior to the start of treatment.
- Participants must have adequate organ function
- Participants must have a tissue sample adequate for translational research. This tissue sample may be obtained from either a newly obtained core or excisional biopsy.
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- Participants must have a life expectancy of greater than 6 months.
- Be at least 18 years of age on the day of signing the informed consent. 8. Female participants: Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of trial medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Note: In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for the participant to start receiving study medication.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) as defined in Appendix 1 OR A WOCBP who agrees to use an adequate method of contraception during the treatment period and for at least 120 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
- The participant (or legally acceptable representative if applicable) must be willing and able to provide written informed consent for the trial. The participant may also provide consent for Future Biomedical Research. However the participant may participate in the main trial without participating in Future Biomedical Research.
Who cannot join
- Participant has metastatic/unresectable cSCC that cannot be potentially cured with surgical resection, radiotherapy, or with a combination of surgery and radiotherapy.
- Participant has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, merkel cell carcinoma, melanoma.
- Participants with any prior allogeneic solid organ or hematopoietic stem cell transplantations are excluded.
- Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- Participant has received prior systemic anti-cancer therapy including investigational agents for cSCC.
- Participant has received prior radiotherapy to the target lesion.
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- Participant has received a live vaccine within 30 days prior to the first dose of trial drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines(eg, FluMist®) are live- attenuated vaccines and are not allowed.
- Participant is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
- Note: Participants who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs) or has a diagnosis of immunodeficiency disorders (such as HIV disease or organ transplantation or hematologic malignancies associated with immune suppression).
- The following are not exclusionary: vitiligo; asthma; type 1 diabetes; hypothyroidism that required only hormone replacement; or psoriasis that does not require systemic treatment.
- Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug.
- Participant has a diagnosis and/or has been treated for additional malignancy within the past 3 years prior to allocation.
- Note: Participants with cSCC of the skin that have undergone potentially curative therapy are not excluded if not related to current diagnosis.
- Note: Participants with basal cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer or melanoma in situ) that have undergone potentially curative therapy are not excluded.
- Note: Participants with low-risk early-stage prostate cancer, defined as below are not excluded: Stage T1c or T2a with a Gleason score 6 and a prostate-specific antigen (PSA) (10 ng/ml) either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to trial allocation.
- Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (eg, with use of disease-modifying agents, anticoagulants, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Participant has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Participant has an active infection requiring systemic therapy.
- Participant has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- Note: No testing for Hepatitis B or Hepatitis C is required unless mandated by a local health authority.
- Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Participant has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the trial.
- Participant is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Jenny Lee, MD, Jenny.Lee@lh.org.au
- Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Brett Hughes, MD, 07 36467983, Brett.Hughes@health.qld.gov.au
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Rahul Ladwa, MD, rahul.ladwa@health.qld.gov.au
About this study
Official title: A Phase 2 Study of De-escalation in Resectable, Locally Advanced Cutaneous Squamous Cell Carcinoma With the Use of Neoadjuvant Pembrolizumab - DESQUAMATE
Cutaneous Squamous Cell Carcinoma (cSCC) is typically associated with a high tumour mutation burden, with the majority caused by Ultraviolet (UV) exposure (Pickering et al., 2014).
The use of this trial using neoadjuvant Pembrolizumab in patients with cSCC who will otherwise undergo highly morbid radical surgical resection has multiple potential advantages, including:
Read more
- Reduction in surgical and radiotherapy morbidity by reducing tumour burden and allowing the appropriate selection of patients to undergo post-operative radiotherapy;
- Provision of immediate information about pathological response and
- Access to tissue to provide insight into resistance mechanisms and identification of biomarkers of response.
The Investigators hypothesized that the use of neoadjuvant Pembrolizumab could reduce tumour burden allowing appropriate selection of patients undergoing radical surgical resection and adjuvant radiotherapy.
- Being tested
- Pembrolizumab
- Keywords
- Pembrolizumab, Immunotherapy, Radiation Therapy, Radiotherapy, Neoadjuvant, Radical Neck Dissection
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called External Beam Radiation Therapy, Radical Neck Dissection
Delivery of neo-adjuvant Pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Neoadjuvant Pembrolizumab 4 cycles, 200mg IV Q3W followed by interval restaging:
If restaging imaging positive will have Radical Neck Resection followed by Pembrolizumab 17 cycles, 200mg IV Q3W +/- External Beam Radiotherapy (if >10% viable tumour cells at resection) If restaging imaging negative will have Mapping biopsy. If biopsy positive will proceed to Radical Neck dissection followed by Pembrolizumab 17 cycles 200mg IV, Q3W If biopsy negative will proceed to Pembrolizumab 17 cycles 200mg IV, Q3W Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the rate of pathological response to neo-adjuvant Pembrolizumab
To assess the rate of pathological response of neo-adjuvant Pembrolizumab in patients with locally advanced, resectable cSCC. Response will be measured by reviewing tissue samples taken at either surgical resection or biopsy following 4 cycles of neo-adjuvant Pembrolizumab. A pathological complete response will show no viable tumour cells.
Pathological response will be determined as:
Major Pathological response (less than or equal to 10% viable tumour cells remaining following 4 cycles of Neo-adjuvant Pembrolizumab) Pathological Partial Response (11-50% of viable tumour cells remaining following 4 cycles of neo-Adjuvant Pembrolizumab) Pathological Stable and/or Progressive disease (greater than 50% viable tumour cells following 4 cycles of Neo-adjuvant Pembrolizumab)
Measured: Will be assessed at the end of Cycle 4 (each cycle is 21 days) of Neo-adjuvant Pembrolizumab.
Secondary outcomes (7)
Objective response Rate
To estimate objective response rate (ORR) as per investigator assessed RECIST 1.1 criteria
Measured: Will be assessed at the end of Cycle 4 (each cycle is 21 days) of Neo-adjuvant Pembrolizumab
Disease free survival
To estimate investigator assessed disease free survival (DFS) per RECIST 1.1 criteria
Measured: From date of drug allocation until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 48 months
Overall Survival
To evaluate the overall survival (OS) of the participants.
Measured: From date of drug allocation until the date of death from any cause, whichever came first, assessed up to 48 months
Locoregional Recurrence
Freedom from locoregional recurrence
Measured: From date of drug allocation until the date of first documented locoregional recurrence or date of death from any cause, whichever came first, assessed up to 48 months
Distant Recurrence
Freedom from Distant Recurrence
Measured: From date of drug allocation until the date of first documented distant recurrence or date of death from any cause, whichever came first, assessed up to 48 months
Incidence of Treatment Emergent Adverse Events related to Pembrolizumab
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE Version 5
Measured: From date of study allocation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Number of Participants with Positive Surgical margins
Positive surgical resection margin defined as tumour cells ≤5mm from the surgical margin.
Measured: At the end of Cycle 4 (cycle length 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start28 Jun 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2027 (estimated)
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 Cutaneous Squamous Cell Carcinoma of the Head and NeckStudies 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
- Multi-centre, open-labelled, non-randomised, single-arm phase 2 study of Pembrolizumab in participants aged 18 years or older with locally advanced (LA) Stage II-IV resectable cSCC.
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queensland Health
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Dr Rahul Ladwa, Queensland Health
- Investigators
- Rahul Ladwa, MD, Principal investigator, Queensland Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025813
- Sponsor's protocol ID
- Ladwa59935
- Acronym
- DESQUAMATE
- Status last verified
- Jul 2022
- First submitted
- 14 Jun 2021
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual data collected during trial in summary
Publications
Ladwa R, Lee JH, McGrath M, Cooper C, Liu H, Bowman J, Gupta R, Cuscaden C, Nottage M, Clark JR, Le D, Pauley M, Kulasinghe A, Gonzalez-Cruz J, Porceddu SV, Hughes BGM, Panizza B. Response-Adapted Surgical and Radiotherapy De-Escalation in Resectable Cutaneous Squamous Cell Cancer Using Pembrolizumab: The De-Squamate Study. J Clin Oncol. 2025 Sep 10;43(26):2888-2896. doi: 10.1200/JCO-25-00387. Epub 2025 Jul 21.
PubMed 40690729
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of De-escalation in Resectable, Locally Advanced Cutaneous Squamous Cell Carcinoma With the Use of Neoadjuvant Pembrolizumab - DESQUAMATE
- ClinicalTrials.gov ID
- NCT05025813
- Acronym / sponsor ID
- DESQUAMATE / Ladwa59935
- Keywords
- Pembrolizumab, Immunotherapy, Radiation Therapy, Radiotherapy, Neoadjuvant, Radical Neck Dissection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Queensland HealthOther government
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Aug 2021 (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.
Cutaneous Squamous Cell Carcinoma (cSCC) is typically associated with a high tumour mutation burden, with the majority caused by Ultraviolet (UV) exposure (Pickering et al., 2014).
The use of this trial using neoadjuvant Pembrolizumab in patients with cSCC who will otherwise undergo highly morbid radical surgical resection has multiple potential advantages, including:
- Reduction in surgical and radiotherapy morbidity by reducing tumour burden and allowing the appropriate selection of patients to undergo post-operative radiotherapy;
- Provision of immediate information about pathological response and
- Access to tissue to provide insight into resistance mechanisms and identification of biomarkers of response.
The Investigators hypothesized that the use of neoadjuvant Pembrolizumab could reduce tumour burden allowing appropriate selection of patients undergoing radical surgical resection and adjuvant radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-centre, open-labelled, non-randomised, single-arm phase 2 study of Pembrolizumab in participants aged 18 years or older with locally advanced (LA) Stage II-IV resectable cSCC.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: PembrolizumabNeoadjuvant Pembrolizumab 4 cycles, 200mg IV Q3W followed by interval restaging: If restaging imaging positive will have Radical Neck Resection followed by Pembrolizumab 17 cycles, 200mg IV Q3W +/- External Beam Radiotherapy (if >10% viable tumour cells at resection) If restaging imaging negative will have Mapping biopsy. If biopsy positive will proceed to Radical Neck dissection followed by Pembrolizumab 17 cycles 200mg IV, Q3W If biopsy negative will proceed to Pembrolizumab 17 cycles 200mg IV, Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed diagnosis of invasive cSCC that is locally advanced (Stage II-IV on AJCC 8th edition) assessed preoperatively as sufficiently high risk that they will warrant post-operatively RT (as recommended by MDT) who is a candidate for a complete resection.
- Note: Participants with tumors arising on cutaneous non-glabrous (hair-bearing) lip with extension onto vermillion (dry red lip) may be eligible after communication and approval from the principal investigator. Participants for whom the primary site is the nose may be eligible after communication and approval from the MDT if the primary site is skin, not nasal mucosa with outward extension to skin. Participants who have squamous cell parotid metastases and have been treated previously for cSCC are permitted. cSCC that has recurred in the same location after 2 or more surgical procedures are not eligible.
- Participants must have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days prior to the start of treatment.
- Participants must have adequate organ function
Key exclusion criteria (24 listed)
- Participant has metastatic/unresectable cSCC that cannot be potentially cured with surgical resection, radiotherapy, or with a combination of surgery and radiotherapy.
- Participant has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, merkel cell carcinoma, melanoma.
- Participants with any prior allogeneic solid organ or hematopoietic stem cell transplantations are excluded.
- Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- Participant has received prior systemic anti-cancer therapy including investigational agents for cSCC.
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 |
|---|---|---|
| PembrolizumabAlso: External Beam Radiation Therapy, Radical Neck DissectionDelivery of neo-adjuvant Pembrolizumab | Drug | Arm A |
Primary outcome
Assess the rate of pathological response to neo-adjuvant Pembrolizumab
Time frame: Will be assessed at the end of Cycle 4 (each cycle is 21 days) of Neo-adjuvant Pembrolizumab.
To assess the rate of pathological response of neo-adjuvant Pembrolizumab in patients with locally advanced, resectable cSCC. Response will be measured by reviewing tissue samples taken at either surgical resection or biopsy following 4 cycles of neo-adjuvant Pembrolizumab. A pathological complete response will show no viable tumour cells. Pathological response will be determined as: Major Pathological response (less than or equal to 10% viable tumour cells remaining following 4 cycles of Neo-adjuvant Pembrolizumab) Pathological Partial Response (11-50% of viable tumour cells remaining following 4 cycles of neo-Adjuvant Pembrolizumab) Pathological Stable and/or Progressive disease (greater than 50% viable tumour cells following 4 cycles of Neo-adjuvant Pembrolizumab)
7 secondary outcomes
Objective response Rate
Time frame: Will be assessed at the end of Cycle 4 (each cycle is 21 days) of Neo-adjuvant Pembrolizumab
Disease free survival
Time frame: From date of drug allocation until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 48 months
Overall Survival
Time frame: From date of drug allocation until the date of death from any cause, whichever came first, assessed up to 48 months
Locoregional Recurrence
Time frame: From date of drug allocation until the date of first documented locoregional recurrence or date of death from any cause, whichever came first, assessed up to 48 months
Distant Recurrence
Time frame: From date of drug allocation until the date of first documented distant recurrence or date of death from any cause, whichever came first, assessed up to 48 months
Incidence of Treatment Emergent Adverse Events related to Pembrolizumab
Time frame: From date of study allocation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Number of Participants with Positive Surgical margins
Time frame: At the end of Cycle 4 (cycle length 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Derived from this study: PubMed 40690729Ladwa R, Lee JH, McGrath M, Cooper C, Liu H, Bowman J, Gupta R, Cuscaden C, Nottage M, Clark JR, Le D, Pauley M, Kulasinghe A, Gonzalez-Cruz J, Porceddu SV, Hughes BGM, Panizza B. Response-Adapted Surgical and Radiotherapy De-Escalation in Resectable Cutaneous Squamous Cell Cancer Using Pembrolizumab: The De-Squamate Study. J Clin Oncol. 2025 Sep 10;43(26):2888-2896. doi: 10.1200/JCO-25-00387. Epub 2025 Jul 21.
- Individual participant dataSharing planned: Yes. All individual data collected during trial in summary
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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.
Rahul Ladwa, MD principal investigator
Queensland Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Cutaneous Squamous Cell Carcinoma of the Head and Neck and Head and Neck Cancer, run by Queensland Health at 3 sites in Australia.
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 11 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahul Ladwa, MD (+61731765479, rahul.ladwa@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the rate of pathological response to neo-adjuvant Pembrolizumab (time frame: Will be assessed at the end of Cycle 4 (each cycle is 21 days) of Neo-adjuvant Pembrolizumab.). 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 NCT05025813, 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 1 Aug 2022.