Gastric CancerPhase 2INFINITYNCT04817826

TremelImumab aNd Durvalumab For the Non-operatIve Management (NOM) of MSI-high Resectable GC/GEJC.

A Phase 2 study testing Durvalumab and Tremelimumab in people with Gastric Cancer and Microsatellite Instability, run by Gruppo Oncologico del Nord-Ovest at 1 site in Italy.

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

INFINITY is a Phase II, multicentre, single-arm, multi-cohort trial aimed at evaluating the activity and safety of the combination of tremelimumab and durvalumab as neoadjuvant (Cohort 1) and definitive (Cohort 2) treatment for MSI-high gastric/gastroesophageal juction cancer patients eligible for radical surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastric Cancer, Microsatellite Instability
What is being tested?: Durvalumab and Tremelimumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteItaly
Study dates: 1 Apr 2021to 1 Feb 2029
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

Written informed consent and any locally required authorization (such as the European Union [EU] Data Privacy Directive) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Age ≥ 18 years old.
ECOG Performance Status 0-1.
Body weight >30 kg.
Diagnosis of resectable gastric or gastroesophageal junction (Siewert II-III) cancer, categorized according to TNM classification 8th edition:
cT ≥ 2, any cN, M0

Show all 18Show fewer

Any cT, cN1-3, M0
Absence of distant metastases as defined by negativity of computed tomography (CT) and 18-fluorodeoxyglucose positron-emission tomography (18-FDG PET).
Life expectancy of at least 12 weeks
MSI-high status confirmed by IHC and multiplex PCR, and EBV-negative status by ISH, as determined centrally at the Co-ordinating Centre. Lack of heterogeneity of dMMR status as showed by lack of tumor cells showing concomitant expression of all 4 protein markers.
Adequate bone marrow and organ function, as defined by laboratory tests:
Neutrophil count ≥ 1.5 x 10^3/μL
Platelet count ≥ 100 x 10^6/μL
Haemoglobin ≥ 9 g/dL
Total bilirubin lower than 1.5 time the upper-normal limits (ULN) of the Institutional normal values
AST (SGOT) and/or ALT (SGPT) < 2.5 x ULN
Creatinine clearance (calculated according to Cockroft and Gault) > 40 mL/min or serum creatinine < 1.5 x ULN.
Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating Centre.

Who cannot join

Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
Previous enrolment in the present study
Participation in another clinical study with an investigational product during the last 12 months
Signs of distant metastases.
Prior medical treatments or irradiation for gastric cancer.
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.

Show all 23Show fewer

Previous treatments with immune checkpoint inhibitors targeting CTLA4, including tremelimumab, PD-1 or PD-L1, including durvalumab.
History of allergy or severe hypersensitivity reaction to monoclonal antibodies.
History of autoimmune diseases or history of organ transplantation that require immunosuppressive therapy. The following are exceptions to this criterion:
Patients with vitiligo or alopecia
Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
Any chronic skin condition that does not require systemic therapy
Patients with celiac disease controlled by diet alone
History of active primary immunodeficiency. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
Any condition requiring systemic treatment with corticosteroids at doses equal or superior to 10 mg daily of prednisone or equivalents, or other immunosuppressive drugs within 14 days from the inclusion in the study. The following medications are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
Administration of live vaccines within 4 weeks from the inclusion in the study. Note: Patients, if enrolled, should not receive live vaccine while receiving study drug(s) and up to 30 days after the last dose of study drug(s).
History of allogenic organ transplantation
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
Women in pregnancy or lactation condition. Women with child-bearing potential or sexually-active men not willing to use adequate contraception during the whole study period.
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, 20133

Other trials in Italy

About this study

Official title: TremelImumab aNd Durvalumab Combination For the Non-operatIve Management (NOM) of Microsatellite InstabiliTY (MSI)-High Resectable Gastric or Gastroesophageal Junction Cancer: The Multicentre, Single-arm, Multi-cohort, Phase II INFINITY Study.

Read the detailed description

This study will pre-screen approximately 310 patients, in order to enrol a total number of 31 patients, 18 in Cohort 1 and 13 in Cohort 2, across 25 Italian Centres.

After central confirmation of MSI-high, dMMR and EBV-negative status, patients with resectable gastric or gastroesophageal junction cancer (Siewert II/III), categorized as cT≥2, any cN, M0 or any cT, cN1-3, M0 according to TNM classification 8th edition, will be enrolled and they will receive a pre-operative treatment with tremelimumab 300 mg single administration (day 1) and durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57).

All patients will undergo a complete disease restaging with chest-abdomen-pelvis CT scan, 18-FDG PET/CT, EUS with biopsies and liquid biopsy.

In Cohort 1, patients will undergo standard gastrectomy with D2 lymphadenectomy between weeks 15 and 18 from enrolment (at least six weeks after the last treatment administration), followed by an active follow-up every 12 weeks for two years and then a standard follow-up every six months until the end of the fifth year from surgery. In Cohort 2, patients with no evidence of complete clinical response (defined as absence of disease persistence at radiological imaging, liquid biopsy and EUS) will be treated as in Cohort 1. Patients with complete clinical response will undergo a non-operative management (NOM) and will start an active follow-up phase every 12 weeks for two years with chest-abdomen-pelvis CT with contrast, 18-FDG PET/TC, if clinically indicated by the Investigator, EUS with multiple random biopsies of the tumor site and FNA of clinically suspicious regional nodes and liquid biopsy, followed by standard follow-up every six months until the end of the fifth year. At any time during follow-up, in case of clinical suspicion or confirmation of residual gastric cancer, either at imaging, pathologically at tissue biopsies/cytological specimens or at ctDNA in liquid biopsy, the patients will undergo standard surgery according to the clinical practice at their Centre (subtotal/total gastrectomy with D2 lymphadenectomy).

Enrolment in Cohort 2 will start only after the completion of enrolment in Cohort 1 and after the extensive evaluation of the final results of Cohort 1 regarding to all endpoints (including exploratory endpoints) and after potential amendment(s) on study design, eligibility criteria and study procedures requested by the Sponsor's Steering Committee and an Independent Data Monitoring Committee made of foreign experts, and after the approval of the Ethics Committee and the Italian Medicines Agency.

Conditions: Gastric Cancer, Microsatellite Instability
Being tested: Durvalumab, Tremelimumab
Keywords: Durvalumab, Tremelimumab, Non-operative management, Surgery, Gastric cancer, Microsatellite Instability
Medical subject headings: Stomach Neoplasms, Microsatellite Instability

What participants receive

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

DurvalumabDrug
durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57).
TremelimumabDrug
tremelimumab 300 mg single administration (day 1)

Study groups in NCT04817826
Study group	Role	What they receive
Cohort 1	Experimental	Pre-operative treatment with tremelimumab 300 mg single administration (day 1) and durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57). Patients in Cohort 1 will undergo standard gastrectomy with D2 lymphadenectomy and then they will be followed by an active follow-up every 12 weeks for two years and then a standard follow-up every six months until the end of the fifth year from surgery. Receives: Drug: Durvalumab; Drug: Tremelimumab
Cohort 2	Experimental	Pre-operative treatment with tremelimumab 300 mg single administration (day 1) and durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57). In Cohort 2, patients with no evidence of complete clinical response will undergo standard gastrectomy with D2 lymphadenectomy and then they will be followed up. Patients with complete clinical response will undergo a non-operative management (NOM) with an active follow-up phase every 12 weeks for two years, followed by standard follow-up every six months until the end of the fifth year. At any time during follow-up, in case of clinical suspicion or confirmation of residual gastric cancer, patients will undergo standard surgery according to the clinical practice at their Centre. Receives: Drug: Durvalumab; Drug: Tremelimumab

What is being measured

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

Primary outcome of Cohort 1: Pathological complete response (ypT0N0) and negative ctDNA status
Rate of patients (%) achieving both pathological complete response (ypT0N0) and negative ctDNA status after neoadjuvant immunotherapy in the intention-to-treat population of Cohort 1
Measured: From the enrollment of the first patient in Cohort 1 up to 4 months from the enrollment of the last patient in Cohort 1
Primary outcome of Cohort 2: 2-year complete response rate
2-year complete response rate, defined as the absence of macroscopic or microscopic residual disease (locally, regionally and distantly) at radiological examinations, tissue and liquid biopsy, in absence of salvage gastrectomy.
Measured: From the enrollment of the first patient in Cohort 2 up to 2 years from the end of pre-operative treatment of the last patient enrolled in Cohort 2

Secondary outcomes (9)

Patients' quality of life
Quality of life will be assessed through Patient reported outcomes (PRO) instrument. EORTC QLQ-C30 For questions 1-28 of EORTC QLQ-C30 a 4-point scale is used. It scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. For the questions 29 and 30 of EORTC QLQ-C30 a 7-points scale is used. It scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
Measured: For each Cohort, from the enrollment of the first patient up to 4 months from the last patient starting the pre-operative treatment phase
Patients' quality of life
Quality of life will be assessed through Patient reported outcomes (PRO) instrument. EORTC QLQ-STO22.
For questions 31-52 of EORTC QLQ-STO22 a 4-point scale is used. It scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.
Measured: For each Cohort, from the enrollment of the first patient up to 4 months from the last patient starting the pre-operative treatment phase
Patients' quality of life
Quality of life will be assessed through Patient reported outcomes (PRO) instrument. EuroQol EQ-5D-5L.
The EQ-5D-5L uses for first 5 questions qualitative multiple choice answers with NO SCALE. For the last questions, a score from 0 to 100 indicates from the worst to the best outcome.
Measured: For each Cohort, from the enrollment of the first patient up to 4 months from the last patient starting the pre-operative treatment phase
3-year disease-free survival
time from the enrollment in the study to the occurrence of disease relapse (local and/or distant), second gastric or gastroesophageal junction cancer primary, or death from any cause.
Measured: For each Cohort, from the enrollment of the first patient up to 3 years from the enrollment of the last patient
5-year overall survival
time from the enrollment in the study to the occurrence of death.
Measured: For each Cohort, from the enrollment of the first patient up to 5 years from the enrollment of the last patient
Metastases-free survival
time from the enrollment in the study to the first evidence of metastases or death from any cause.
Measured: For each Cohort, from the enrollment of the first patient up to 5 years from the enrollment of the last patient
Gastrectomy-free survival (Cohort 2 only)
time from the inclusion in the study to the occurrence of gastrectomy or death from any cause.
Measured: From the enrollment of the first patient up to 5 years from the enrollment of the last patient
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
incidence of adverse events during the treatment and follow-up phases, assessed according to CTCAE v5.0.
Measured: For each Cohort, from the enrollment of the first patient up to 5 years from the enrollment of the last patient
Post gastrectomy complications
Rate of post-gastrectomy complications following tremelimumab and durvalumab as pre-operative treatment strategy.
Measured: For each Cohort, from the enrollment of the first patient up to 1 year from the enrollment of the last patient

Timeline

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

1 Apr 20211 Feb 2029

First posted26 Mar 2021
Study start1 Apr 2021
Primary completion1 Feb 2026
Study completion1 Feb 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies 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: Non-randomised
Intervention model: Single group
Model description: Phase II, multicentre, single-arm, multi-cohort trial.
Masking: None (open label)
Enrolment: 31 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04817826
Sponsor's protocol ID: 2020-003440-92
Acronym: INFINITY
Status last verified: Sep 2026
First submitted: 11 Mar 2021
Last updated: 11 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The trial results concerning the primary, secondary and exploratory outcomes will be published according to the standard guidelines. IPD could eventually be requested to the Sponsor and Principal Investigator, who will carefully evaluate the formal and motivated request.

Publications

Chalabi M, Fanchi LF, Dijkstra KK, Van den Berg JG, Aalbers AG, Sikorska K, Lopez-Yurda M, Grootscholten C, Beets GL, Snaebjornsson P, Maas M, Mertz M, Veninga V, Bounova G, Broeks A, Beets-Tan RG, de Wijkerslooth TR, van Lent AU, Marsman HA, Nuijten E, Kok NF, Kuiper M, Verbeek WH, Kok M, Van Leerdam ME, Schumacher TN, Voest EE, Haanen JB. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med. 2020 Apr;26(4):566-576. doi: 10.1038/s41591-020-0805-8. Epub 2020 Apr 6.
PubMed 32251400
Klute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044.
PubMed 40340830
Raimondi A, Lonardi S, Murgioni S, Cardellino GG, Tamberi S, Strippoli A, Palermo F, De Manzoni G, Bencivenga M, Bittoni A, Chiodoni C, Lorenzini D, Todoerti K, Manca P, Sangaletti S, Prisciandaro M, Randon G, Nichetti F, Bergamo F, Brich S, Belfiore A, Bertolotti A, Stetco D, Guidi A, Torelli T, Vingiani A, Joshi RP, Khoshdeli M, Beaubier N, Stumpe MC, Nappo F, Leone AG, Pircher CC, Leoncini G, Sabella G, Airo' Farulla L, Alessi A, Morano F, Martinetti A, Niger M, Fassan M, Di Maio M, Kaneva K, Milione M, Nimeiri H, Sposito C, Agnelli L, Mazzaferro V, Di Bartolomeo M, Pietrantonio F. Tremelimumab and durvalumab as neoadjuvant or non-operative management strategy of patients with microsatellite instability-high resectable gastric or gastroesophageal junction adenocarcinoma: the INFINITY study by GONO. Ann Oncol. 2025 Mar;36(3):285-296. doi: 10.1016/j.annonc.2024.11.016. Epub 2024 Dec 3.
PubMed 39637944

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

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TremelImumab aNd Durvalumab Combination For the Non-operatIve Management (NOM) of Microsatellite InstabiliTY (MSI)-High Resectable Gastric or Gastroesophageal Junction Cancer: The Multicentre, Single-arm, Multi-cohort, Phase II INFINITY Study.
ClinicalTrials.gov ID: NCT04817826
Acronym / sponsor ID: INFINITY / 2020-003440-92
Conditions: Gastric Cancer, Microsatellite Instability
Keywords: Durvalumab, Tremelimumab, Non-operative management, Surgery, Gastric cancer, Microsatellite Instability
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 31 participants (estimated)
Lead sponsor: Gruppo Oncologico del Nord-OvestUniversity, hospital or other
Study start: 1 Apr 2021 (actual)
Primary completion: 1 Feb 2026 (actual)
Study completion: 1 Feb 2029 (estimated)
First posted: 26 Mar 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.

Detailed description

This study will pre-screen approximately 310 patients, in order to enrol a total number of 31 patients, 18 in Cohort 1 and 13 in Cohort 2, across 25 Italian Centres.

All patients will undergo a complete disease restaging with chest-abdomen-pelvis CT scan, 18-FDG PET/CT, EUS with biopsies and liquid biopsy.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: Phase II, multicentre, single-arm, multi-cohort trial.

Arm	Type	Receives
Cohort 1	Experimental	Drug: Durvalumab, Drug: TremelimumabPre-operative treatment with tremelimumab 300 mg single administration (day 1) and durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57). Patients in Cohort 1 will undergo standard gastrectomy with D2 lymphadenectomy and then they will be followed by an active follow-up every 12 weeks for two years and then a standard follow-up every six months until the end of the fifth year from surgery.
Cohort 2	Experimental	Drug: Durvalumab, Drug: TremelimumabPre-operative treatment with tremelimumab 300 mg single administration (day 1) and durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57). In Cohort 2, patients with no evidence of complete clinical response will undergo standard gastrectomy with D2 lymphadenectomy and then they will be followed up. Patients with complete clinical response will undergo a non-operative management (NOM) with an active follow-up phase every 12 weeks for two years, followed by standard follow-up every six months until the end of the fifth year. At any time during follow-up, in case of clinical suspicion or confirmation of residual gastric cancer, patients will undergo standard surgery according to the clinical practice at their Centre.

Who may qualify

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

Key inclusion criteria (18 listed)

Written informed consent and any locally required authorization (such as the European Union [EU] Data Privacy Directive) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Age ≥ 18 years old.
ECOG Performance Status 0-1.
Body weight >30 kg.
Diagnosis of resectable gastric or gastroesophageal junction (Siewert II-III) cancer, categorized according to TNM classification 8th edition:

Key exclusion criteria (23 listed)

Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
Previous enrolment in the present study
Participation in another clinical study with an investigational product during the last 12 months
Signs of distant metastases.
Prior medical treatments or irradiation for gastric cancer.

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
Durvalumabdurvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57).	Drug	Cohort 1, Cohort 2
Tremelimumabtremelimumab 300 mg single administration (day 1)	Drug	Cohort 1, Cohort 2

Primary outcome

Primary outcome of Cohort 1: Pathological complete response (ypT0N0) and negative ctDNA status
Time frame: From the enrollment of the first patient in Cohort 1 up to 4 months from the enrollment of the last patient in Cohort 1
Rate of patients (%) achieving both pathological complete response (ypT0N0) and negative ctDNA status after neoadjuvant immunotherapy in the intention-to-treat population of Cohort 1
Primary outcome of Cohort 2: 2-year complete response rate
Time frame: From the enrollment of the first patient in Cohort 2 up to 2 years from the end of pre-operative treatment of the last patient enrolled in Cohort 2
2-year complete response rate, defined as the absence of macroscopic or microscopic residual disease (locally, regionally and distantly) at radiological examinations, tissue and liquid biopsy, in absence of salvage gastrectomy.

9 secondary outcomes

Patients' quality of life
Time frame: For each Cohort, from the enrollment of the first patient up to 4 months from the last patient starting the pre-operative treatment phase
Patients' quality of life
Time frame: For each Cohort, from the enrollment of the first patient up to 4 months from the last patient starting the pre-operative treatment phase
Patients' quality of life
Time frame: For each Cohort, from the enrollment of the first patient up to 4 months from the last patient starting the pre-operative treatment phase
3-year disease-free survival
Time frame: For each Cohort, from the enrollment of the first patient up to 3 years from the enrollment of the last patient
5-year overall survival
Time frame: For each Cohort, from the enrollment of the first patient up to 5 years from the enrollment of the last patient
Metastases-free survival
Time frame: For each Cohort, from the enrollment of the first patient up to 5 years from the enrollment of the last patient
Gastrectomy-free survival (Cohort 2 only)
Time frame: From the enrollment of the first patient up to 5 years from the enrollment of the last patient
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: For each Cohort, from the enrollment of the first patient up to 5 years from the enrollment of the last patient
Post gastrectomy complications
Time frame: For each Cohort, from the enrollment of the first patient up to 1 year from the enrollment of the last patient

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 11 Sep 2026.
Background: PubMed 32251400Chalabi M, Fanchi LF, Dijkstra KK, Van den Berg JG, Aalbers AG, Sikorska K, Lopez-Yurda M, Grootscholten C, Beets GL, Snaebjornsson P, Maas M, Mertz M, Veninga V, Bounova G, Broeks A, Beets-Tan RG, de Wijkerslooth TR, van Lent AU, Marsman HA, Nuijten E, Kok NF, Kuiper M, Verbeek WH, Kok M, Van Leerdam ME, Schumacher TN, Voest EE, Haanen JB. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med. 2020 Apr;26(4):566-576. doi: 10.1038/s41591-020-0805-8. Epub 2020 Apr 6.
Derived from this study: PubMed 40340830Klute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044.
Derived from this study: PubMed 39637944Raimondi A, Lonardi S, Murgioni S, Cardellino GG, Tamberi S, Strippoli A, Palermo F, De Manzoni G, Bencivenga M, Bittoni A, Chiodoni C, Lorenzini D, Todoerti K, Manca P, Sangaletti S, Prisciandaro M, Randon G, Nichetti F, Bergamo F, Brich S, Belfiore A, Bertolotti A, Stetco D, Guidi A, Torelli T, Vingiani A, Joshi RP, Khoshdeli M, Beaubier N, Stumpe MC, Nappo F, Leone AG, Pircher CC, Leoncini G, Sabella G, Airo' Farulla L, Alessi A, Morano F, Martinetti A, Niger M, Fassan M, Di Maio M, Kaneva K, Milione M, Nimeiri H, Sposito C, Agnelli L, Mazzaferro V, Di Bartolomeo M, Pietrantonio F. Tremelimumab and durvalumab as neoadjuvant or non-operative management strategy of patients with microsatellite instability-high resectable gastric or gastroesophageal junction adenocarcinoma: the INFINITY study by GONO. Ann Oncol. 2025 Mar;36(3):285-296. doi: 10.1016/j.annonc.2024.11.016. Epub 2024 Dec 3.
Individual participant dataSharing planned: No. The trial results concerning the primary, secondary and exploratory outcomes will be published according to the standard guidelines. IPD could eventually be requested to the Sponsor and Principal Investigator, who will carefully evaluate the formal and motivated request.

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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.

Filippo Pietrantonio, MD principal investigator

Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab and Tremelimumab in people with Gastric Cancer and Microsatellite Instability, run by Gruppo Oncologico del Nord-Ovest at 1 site in Italy.

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 18 inclusion and 23 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 11 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 1 site in Italy. 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?

Primary outcome of Cohort 1: Pathological complete response (ypT0N0) and negative ctDNA status (time frame: From the enrollment of the first patient in Cohort 1 up to 4 months from the enrollment of the last patient in Cohort 1). The study lists 2 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 NCT04817826, which also lists 3 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.