Neoplasms, Head and NeckPhase 2NCT06062420

A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202

A Phase 2 study testing Dostarlimab, Belrestotug and Nelistotug in people with Neoplasms, Head and Neck, run by GlaxoSmithKline at 108 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms, Head and Neck
What is being tested?: Dostarlimab, Belrestotug and Nelistotug
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 316 participants
Where: 108 sitesin 20 countries
Study dates: 14 Nov 2023to 31 Dec 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

Have histologically or cytologically-confirmed HNSCC that is R/M and is considered incurable by local therapies. A) Subjects must not have had prior systemic therapy administered in the R/M setting. Chemoradiation therapy which was completed more than 4 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed B) The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx C) Subjects may not have a primary tumor site of nasopharynx (any histology)
Has measurable (target) disease based on RECIST 1.1 as determined by the investigator.
Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of R/M HNSCC. A fresh tumor tissue sample obtained within 90 days of screening is highly preferred, If fresh biopsy is not possible, an archival tumor specimen is acceptable unless it was obtained prior to administration of chemoradiation for the treatment of a participant's tumor. Needle or excisional biopsies or resected tissue is required. Cytological specimens such as fine needle aspirates, bone marrow samples, or cell blocks are not acceptable. Bone specimen is not acceptable.
Has tumor Programmed death ligand 1 (PD-L1) expression
If the primary tumor site is oropharyngeal carcinoma, the participant must have Human papillomavirus (HPV) results

Who cannot join

Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting Programmed death protein 1 (PD-1), PD-L1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine based inhibitory motif domains (TIGIT), Cluster of differentiation (CD) 96, or other immune checkpoint pathways.
Participants with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, esophageal, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
Have active tumor bleeding or a high risk of bleeding (examples include but are not limited to radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrates >90 degree abutment or encasement of a major vessel [carotid, jugular, bronchial artery] and/or exhibits other high-risk features such as arteriovenous fistula).
Has PD within 4 months of completion of curatively intended treatment for locoregionally advanced HNSCC
Participants with any carcinomatous meningitis or leptomeningeal spread and those with uncontrolled or symptomatic Central Nervous System (CNS) metastases
Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years. (Stable, medically managed autoimmune endocrinopathies are acceptable if participant otherwise meets entry criteria.)

Trial locations and contacts

108 sites in 20 countries.

Country

City, postcode or hospital

108 sites in 20 countries

Spain13 sites

GSK Investigational Site
Barcelona, 08023
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08907
GSK Investigational Site
Jaén, 23007
GSK Investigational Site
Madrid, 28010
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Pozuelo de AlarcOn Madr, 28223
GSK Investigational Site
Salamanca, 37007
GSK Investigational Site
Santander, 39008
GSK Investigational Site
Valencia, 46009
GSK Investigational Site
Zaragoza, 50009

Other trials in Spain

Italy11 sites

GSK Investigational Site
Bari, 70124
GSK Investigational Site
Bologna, 40139
GSK Investigational Site
Florence, 50134
GSK Investigational Site
Genova, 16132
GSK Investigational Site
Milan, 20133
GSK Investigational Site
Naples, 80131
GSK Investigational Site
Novara, 28100
GSK Investigational Site
Padova, 35128
GSK Investigational Site
Roma, 00144
GSK Investigational Site
Roma, 00168
GSK Investigational Site
Rozzano, MI, 20089

Other trials in Italy

Romania11 sites

GSK Investigational Site
Brasov, 500283
GSK Investigational Site
Bucharest, 020142
GSK Investigational Site
Bucharest, 022328
GSK Investigational Site
Bucharest, 030171
GSK Investigational Site
Bucharest, 30463
GSK Investigational Site
Craiova, 200542
GSK Investigational Site
Floreşti, 407280
GSK Investigational Site
Iași, 700483
GSK Investigational Site
Oradea, 410469
GSK Investigational Site
Piteşti, 110283
GSK Investigational Site
Suceava, 720214

Other trials in Romania

Argentina8 sites

GSK Investigational Site
Buenos Aires, C1426ABP
GSK Investigational Site
Capital Federal, C1181ACH
GSK Investigational Site
Ciudad Autonoma de Bueno, C1056ABI
GSK Investigational Site
Córdoba, 5000
GSK Investigational Site
Florida, B1602DQD
GSK Investigational Site
Mendoza, M5500AYB
GSK Investigational Site
San Juan, 5400
GSK Investigational Site
Santa Fe, 3000

Other trials in Argentina

Germany8 sites

GSK Investigational Site
Aachen, 52074
GSK Investigational Site
Berlin, 12203
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122
GSK Investigational Site
Frankfurt am Main, Hesse, 60488
GSK Investigational Site
Giessen, 35392
GSK Investigational Site
Hamburg, 20246
GSK Investigational Site
Regensburg, 93053
GSK Investigational Site
Ulm, 89075

Other trials in Germany

Japan7 sites

GSK Investigational Site
Aichi, 464-8681
GSK Investigational Site
Chiba, 277-8577
GSK Investigational Site
Hyōgo, 650-0017
GSK Investigational Site
Osaka, 541-8567
GSK Investigational Site
Saitama, 350-1298
GSK Investigational Site
Shizuoka, 411-8777
GSK Investigational Site
Tokyo, 104-0045

Other trials in Japan

France6 sites

GSK Investigational Site
Bordeaux, 33075
GSK Investigational Site
Caen, 14075
GSK Investigational Site
Marseille, 13005
GSK Investigational Site
Paris, 75005
GSK Investigational Site
Rouen, 76038
GSK Investigational Site
Villejuif, 94805

Other trials in France

Poland6 sites

GSK Investigational Site
Bielsko-Biala, 43-300
GSK Investigational Site
Katowice, 40-514
GSK Investigational Site
Krakow, 31-826
GSK Investigational Site
Przemyśl, 37-700
GSK Investigational Site
Siedlce, 08-110
GSK Investigational Site
Warsaw, 04-141

Other trials in Poland

United States5 sites

GSK Investigational Site
Columbus, Ohio, 43210
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
New Haven, Connecticut, 06511
GSK Investigational Site
St Louis, Missouri, 63110-1010

Other trials in United States

Canada5 sites

GSK Investigational Site
Calgary, Alberta, T2N 5G2
GSK Investigational Site
Edmonton, Alberta, T6G 1Z2
GSK Investigational Site
Montreal, Quebec, H3T 1E2
GSK Investigational Site
Toronto, Ontario, M4N 3M5
GSK Investigational Site
Toronto, Ontario, M5G 2M9

Other trials in Canada

South Korea5 sites

GSK Investigational Site
Daegu, 42601
GSK Investigational Site
Seongnam-si Gyeonggi-do, 13620
GSK Investigational Site
Seoul, 03722
GSK Investigational Site
Seoul, 138-736
GSK Investigational Site
Suwon Kyunggi-do, 443-721

Other trials in South Korea

Portugal4 sites

GSK Investigational Site
Almada, 2801-951
GSK Investigational Site
Lisbon, 1649-035
GSK Investigational Site
Porto, 4099-001
GSK Investigational Site
Porto, 4200-072

Other trials in Portugal

Taiwan4 sites

GSK Investigational Site
Changhua, 500
GSK Investigational Site
Tainan, 704
GSK Investigational Site
Taipei, 10002
GSK Investigational Site
Taipei, 11217

Other trials in Taiwan

Brazil3 sites

GSK Investigational Site
Santo André, 09060-650
GSK Investigational Site
São Paulo, 01221-020
GSK Investigational Site
São Paulo, 01246-000

Other trials in Brazil

Greece3 sites

GSK Investigational Site
Haidari - Athens, 12462
GSK Investigational Site
Marousi
GSK Investigational Site
Panórama, Central Macedonia, 552 36

Other trials in Greece

Hungary3 sites

GSK Investigational Site
Győr, 9024
GSK Investigational Site
Kecskemét, 6000
GSK Investigational Site
Pécs, 7624

Other trials in Hungary

Turkey (Türkiye)3 sites

GSK Investigational Site
Ankara, 06100
GSK Investigational Site
Istanbul, 34662
GSK Investigational Site
Izmir, 35040

Other trials in Turkey (Türkiye)

Denmark1 site

GSK Investigational Site
Herlev

Other trials in Denmark

Finland1 site

GSK Investigational Site
Turku, 20520

Other trials in Finland

Norway1 site

GSK Investigational Site
Oslo, 0379

Other trials in Norway

About this study

Official title: A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

Conditions: Neoplasms, Head and Neck
Being tested: Dostarlimab, Belrestotug, Nelistotug, Remzistotug
Keywords: Dostarlimab, Belrestotug, Nelistotug, Remzistotug, PD-L1, HNSCC
Medical subject headings: Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

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

DostarlimabDrug
Dostarlimab will be administered.
BelrestotugDrug
Belrestotug will be administered.
NelistotugDrug
Nelistotug will be administered.
RemzistotugDrug
Remzistotug will be administered.

Study groups in NCT06062420
Study group	Role	What they receive
Dostarlimab Monotherapy	Experimental	Not described Receives: Drug: Dostarlimab
Sub study 1: Dostarlimab and Belrestotug	Experimental	Not described Receives: Drug: Dostarlimab; Drug: Belrestotug
Sub study 2: Dostarlimab and nelistotug	Experimental	Not described Receives: Drug: Dostarlimab; Drug: Nelistotug
Sub study 3: Dosarlimab and Belrestotug and nelistotug	Experimental	Not described Receives: Drug: Dostarlimab; Drug: Belrestotug; Drug: Nelistotug
Sub study 4: Dostarlimab and remzistotug	Experimental	Not described Receives: Drug: Dostarlimab; Drug: Remzistotug

What is being measured

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

Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy
Confirmed ORR is defined as the percentage of participants achieving confirmed Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.
Measured: Up to approximately 24 months

Secondary outcomes (3)

Number of Participants with Treatment Emergent Adverse Events (AEs), treatment emergent Serious Adverse Events (SAE) and treatment emergent Adverse Events of Special Interest (AESI)
Measured: Up to approximately 24 months
Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation
Measured: Up to approximately 24 months
Number of Participants with Clinically Significant Findings in Vital signs, Electrocardiogram (ECG), and Laboratory test parameters
Measured: Up to approximately 24 months

Timeline

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

14 Nov 202331 Dec 2027

First posted2 Oct 2023
Study start14 Nov 2023
Primary completion10 Sep 2026
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neoplasms, Head and NeckStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: 316 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06062420
Sponsor's protocol ID: 219885
Other IDs: 2023-503428-24, 2023
Status last verified: Sep 2026
First submitted: 21 Sep 2023
Last updated: 24 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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?

See locations

Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
Active, not recruitingPhase 2
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer
Head and Neck Cancer
RecruitingPhase 2
Zemetostat With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma
Soft Tissue Sarcoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma

All Neoplasms, Head and Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
ClinicalTrials.gov ID: NCT06062420
Acronym / sponsor ID: 219885
Conditions: Neoplasms, Head and Neck
Keywords: Dostarlimab, Belrestotug, Nelistotug, Remzistotug, PD-L1, HNSCC
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 316 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: iTeos Therapeutics
Study start: 14 Nov 2023 (actual)
Primary completion: 10 Sep 2026 (actual)
Study completion: 31 Dec 2027 (estimated)
First posted: 2 Oct 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Dostarlimab Monotherapy	Experimental	Drug: Dostarlimab
Sub study 1: Dostarlimab and Belrestotug	Experimental	Drug: Dostarlimab, Drug: Belrestotug
Sub study 2: Dostarlimab and nelistotug	Experimental	Drug: Dostarlimab, Drug: Nelistotug
Sub study 3: Dosarlimab and Belrestotug and nelistotug	Experimental	Drug: Dostarlimab, Drug: Belrestotug, Drug: Nelistotug
Sub study 4: Dostarlimab and remzistotug	Experimental	Drug: Dostarlimab, Drug: Remzistotug

Who may qualify

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

Key inclusion criteria (6 listed)

Have histologically or cytologically-confirmed HNSCC that is R/M and is considered incurable by local therapies. A) Subjects must not have had prior systemic therapy administered in the R/M setting. Chemoradiation therapy which was completed more than 4 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed B) The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx C) Subjects may not have a primary tumor site of nasopharynx (any histology)
Has measurable (target) disease based on RECIST 1.1 as determined by the investigator.
Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of R/M HNSCC. A fresh tumor tissue sample obtained within 90 days of screening is highly preferred, If fresh biopsy is not possible, an archival tumor specimen is acceptable unless it was obtained prior to administration of chemoradiation for the treatment of a participant's tumor. Needle or excisional biopsies or resected tissue is required. Cytological specimens such as fine needle aspirates, bone marrow samples, or cell blocks are not acceptable. Bone specimen is not acceptable.
Has tumor Programmed death ligand 1 (PD-L1) expression

Key exclusion criteria (6 listed)

Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting Programmed death protein 1 (PD-1), PD-L1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine based inhibitory motif domains (TIGIT), Cluster of differentiation (CD) 96, or other immune checkpoint pathways.
Participants with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, esophageal, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
Have active tumor bleeding or a high risk of bleeding (examples include but are not limited to radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrates >90 degree abutment or encasement of a major vessel [carotid, jugular, bronchial artery] and/or exhibits other high-risk features such as arteriovenous fistula).
Has PD within 4 months of completion of curatively intended treatment for locoregionally advanced HNSCC
Participants with any carcinomatous meningitis or leptomeningeal spread and those with uncontrolled or symptomatic Central Nervous System (CNS) metastases

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
DostarlimabDostarlimab will be administered.	Drug	Dostarlimab Monotherapy, Sub study 1: Dostarlimab and Belrestotug, Sub study 2: Dostarlimab and nelistotug, Sub study 3: Dosarlimab and Belrestotug and nelistotug, Sub study 4: Dostarlimab and remzistotug
BelrestotugBelrestotug will be administered.	Drug	Sub study 1: Dostarlimab and Belrestotug, Sub study 3: Dosarlimab and Belrestotug and nelistotug
NelistotugNelistotug will be administered.	Drug	Sub study 2: Dostarlimab and nelistotug, Sub study 3: Dosarlimab and Belrestotug and nelistotug
RemzistotugRemzistotug will be administered.	Drug	Sub study 4: Dostarlimab and remzistotug

Primary outcome

Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy
Time frame: Up to approximately 24 months
Confirmed ORR is defined as the percentage of participants achieving confirmed Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.

3 secondary outcomes

Number of Participants with Treatment Emergent Adverse Events (AEs), treatment emergent Serious Adverse Events (SAE) and treatment emergent Adverse Events of Special Interest (AESI)
Time frame: Up to approximately 24 months
Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 24 months
Number of Participants with Clinically Significant Findings in Vital signs, Electrocardiogram (ECG), and Laboratory test parameters
Time frame: Up to approximately 24 months

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 24 Sep 2026.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Related trials for Neoplasms, Head and Neck

Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
Active, not recruitingPhase 2
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer
Head and Neck Cancer
RecruitingPhase 2
Zemetostat With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma
Soft Tissue Sarcoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma

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.

GSK Clinical Trials study director

GlaxoSmithKline

108 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dostarlimab, Belrestotug and Nelistotug in people with Neoplasms, Head and Neck, run by GlaxoSmithKline at 108 sites in 20 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in Spain, Italy, Romania, Argentina, Germany and 15 more countries. 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?

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?

Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy (time frame: Up to approximately 24 months). 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 NCT06062420.

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 24 Sep 2026.