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Gastric AdenocarcinomaPhase 2IMMUNOGASTNCT04739202

Personalized Targeted IMMUNOtherapy-based Regimens in Recurrent GASTric Adenocarcinoma (IMMUNOGAST)

A Phase 2 study testing Atezolizumab + Ipatasertib and Atezolizumab + Bevacizumab in people with Gastric Adenocarcinoma and Metastatic Gastric Cancer, run by Hospices Civils de Lyon at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

For patients with advanced/metastatic gastric adenocarcinomas in progression after a first line chemotherapy comprising platinum and fluoropyrimidine, the reported second line treatments are : 1) paclitaxel combined with ramucirumab (overall response rate (ORR) = 25%; median progression free survival (PFS) = 2.9… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab + Ipatasertib and Atezolizumab + Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
8 sitesFrance
Study dates
19 Mar 2021to 4 Jun 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

  • Histologically and/or cytologically documented recurrent advanced/metastatic gastric or gastroesophageal junction adenocarcinomas* previously treated with a platinum and fluoropyrimidine-based regimen.
  • The gastric or gastroesophageal junction adenocarcinomas that overexpress HER2 should have previously been treated with trastuzumab, except in the case of contraindication.
  • Patients older than 18 years
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Patients must have documented disease progression
  • Patients who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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  • Accessible tumor lesion (primitive lesion or metastasis) for trial dedicated tumor biopsy.
  • Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (echo) or multigated acquisition (MUGA) scan within 28 days before day 1 of treatment.
  • Child-Pugh class A
  • Patients must have normal organ and marrow function:
  • Absolute neutrophil count ≥ 1,500/μL, platelets ≥ 100,000/μL, hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 ULN except subject with documented Gilbert's syndrome, AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN, Serum alkaline phosphatase ≤ 2.5 x ULN. Patients with bone metastases: alkaline phosphatase ≤ 5 x ULN.
  • Albumin > 2.5 mg/dL.
  • Glomerular filtration rate ≥ 60 mL/min as determined by the CKD-EPI equation (or reference methodology such as Iohexol or isotopic technic).
  • Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24-hour urine must demonstrate < 1 g of protein in 24 hours.
  • Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).
  • Female patients of childbearing potential must have a negative serum pregnancy test within 8 days of initiating protocol therapy.
  • Female patients of childbearing potential must agree to use contraceptive methods with a low failure rate (< 1% per year) during the treatment period and for 6 months after the last dose of study drugs.
  • Male patients of childbearing potential must agree to use contraceptive methods with a low failure rate during the treatment period and for 6 months after the last dose of study drugs.
  • Patient is capable of understanding and complying with the protocol and has signed the informed consent document.
  • Patients affiliated to a social insurance regime.

Who cannot join

  • Residual toxicity from previous treatment grade ≥1, except for alopecia or peripheral neuropathy grade ≤ 2
  • Radiotherapy within 28 days before inclusion, except for palliative radiotherapy if patients recovered from all side effects
  • Congenital risk of bleeding, or acquired coagulopathy, or curative anti-coagulant therapies (except for low molecular weight heparin).
  • Active digestive bleeding within 3 months before inclusion
  • Patients pretreated with one of the experimental drugs, other immune checkpoint inhibitor anti-cancer drugs (anti-PD1, anti-PDL1, anti-CTLA4, …), or with ramucirumab.
  • Uncontrolled high cholesterol or triglyceride grade ≥ 2
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  • Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure-New York Heart Association Class III or IV, active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, gastric or duodenal ulceration diagnosed within the previous 6 months, chronic liver or renal disease, or severe malnutrition.
  • Current peripheral neuropathy of Grade ≥ 3 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0
  • Active, second potentially life-threatening cancer
  • Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS). Patient with a history of localized malignancy diagnosed over 5 years ago may be eligible provided he completed her adjuvant systemic therapy and remains free of recurrent or metastatic disease.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). 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 without active disease in the last 5 years may be included but only after consultation with the study physician
  • Major surgery within 28 days before cycle 1, day 1
  • Active infection requiring iv antibiotics at day 1 of cycle 1
  • Medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication. For example, patients with autoimmune disease that requires systemic steroids or immunosuppression agents should be excluded. Replacement therapy (eg., thyroxine, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
  • Patient is positive for the human immunodeficiency virus (HIV), HepBsAg, or HCV RNA.
  • Live vaccine within 28 days of planned start of study therapy
  • History of abdominal fistula, gastrointestinal perforation and/or intra-abdominal abscess within the previous 6 months
  • History of Type I or Type II diabetes mellitus requiring insulin
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins or Chinese Hamster Ovary (CHO) cell proteins or loperamide drug or excipient
  • Known hypersensitivity to any of the components of atezolizumab, bevacizumab or ipatasertib
  • Participation in other interventional clinical research that may interfere with the experimental drugs efficacy
  • History of severe or life-threatening skin adverse reaction on prior treatment with other immune-stimulatory anticancer agents

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Dijon - Centre Georges-Francois Leclerc

    Dijon, 21000

  • Hcl - Hopital Edouard Herriot

    Lyon, 69003

  • Aphm - Hopital La Timone

    Marseille, 13385

  • Aphp - Hopital Saint-Louis

    Paris, 75010

  • Aphp - Hopital Pitie Salpetriere

    Paris, 75013

  • Bordeaux - Hopital Haut-Leveque

    Pessac, 33604

  • Hcl - Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Toulouse - Iuct Rangueil-Larrey

    Toulouse, 31059

Other trials in France

About this study

Official title: An Umbrella Phase 2 Trial to Assess Personalized Targeted IMMUNOtherapy-based Regimens in Recurrent Advanced/Metastatic GASTric Adenocarcinoma Patients

For patients with advanced/metastatic gastric adenocarcinomas in progression after a first line chemotherapy comprising platinum and fluoropyrimidine, the reported second line treatments are : 1) paclitaxel combined with ramucirumab (overall response rate (ORR) = 25%; median progression free survival (PFS) = 2.9 months; median overall survival (OS)= 5.9 months), or paclitaxel alone (ORR = 14%, median PFS = 2.9 months; median OS= 5.9 months); 2) docetaxel (ORR = 7%, median OS = 5.2 months) or 3) irinotecan (ORR = 0%, median OS= 4.0 months).

These numbers demonstrate the poor prognosis of this disease, and the unmet medical need for innovative therapeutic strategies.

Read more

Cancer Genome Atlas (TCGA) mapped a genomic landscape of gastric adenocarcinomas, and identified 4 sub-types:

  • Tumor positive for Epstein-Barr virus (EBV) (8%), which display recurrent PIK3CA mutations, extreme DNA hypermethylation, and amplification of JAK2, ErbB2, PD-L1 and PD-L2;
  • Microsatellite instable tumors (MSI-high) (22%), which show elevated mutation rates, including mutations of genes encoding targetable oncogenic signaling proteins (PIK3CA, ErbB2, ErbB3, and EGFR);
  • Genomically stable tumors (20%), which are enriched for the diffuse histological variant and mutations of RHOA or fusions involving RHO-family GTPase-activating proteins;
  • Tumors with chromosomal instability (50%), which show marked aneuploidy and focal amplification of receptor tyrosine kinases and VEGFA.

Most of diffuse-type gastric adenocarcinomas were classified in genomically stable tumors. This subgroup of cancers, accounting for about 20 to 30% of gastric adenocarcinomas, is associated with particularly poor prognosis and resistance to chemotherapy. A proteomic landscape of diffuse-type gastric adenocarcinomas was recently reported.

Pembrolizumab, an anti-PDL1 drug granted with an accelerated approval by FDA in September 2017, exhibited promising activity in gastric adenocarcinoma patients previously treated with 1 or 2 lines of chemotherapy (ORR=11.6%, median PFS = 2.0 months, median OS= 5.6 months), especially in those with PDL1 positive tumors (ORR=22.7%). The tumor response was particularly high in patients with MSI-high tumor (ORR=57.1%). However the preliminary outcomes of the phase III KEYNOTE-061 trial (NCT02370498) recently released in the press suggest that pembrolizumab was not superior to paclitaxel in 592 patients with advanced gastric or gastroesophageal junction adenocarcinoma whose disease progressed after first-line treatment with platinum and fluoropyrimidine doublet therapy (the hazard ratio (HR) for OS was 0.82 (95% confidence interval = 0.66-1.03; one sided P = .042) (http://www.ascopost.com/News/58377).

These outcomes suggest that, although being very promising, immunotherapy should be combined to other agents for being fully effective in gastric adenocarcinomas patients.

We propose a strategy based on molecular features to select the drugs that will be associated with atezolizumab, an anti-PDL1 drug, in patients with pre-treated advanced gastric adenocarcinomas:

  • Patients with tumors positive for EBV or microsatellite instable tumors (30%) will be treated with atezolizumab and ipatasertib.
  • Patients with genomically stable tumors (20%) will be treated with atezolizumab combined with bevacizumab.
  • Patients with tumors with chromosomal instability (50%) will be treated with atezolizumab combined with bevacizumab.

Expected outcomes:

IMMUNOGAST trial will provide data about the clinical feasibility of biomolecular characterization of gastric adenocarcinomas for routine treatment adjustment. Moreover it should generate information about the relevance of adjusting combined immunotherapies based on molecular subtypes, in terms of clinical efficacy. Finally, translational research project outcomes should provide important data about relationships between efficacy and tumor immune gene spatial expression, along with tumor and circulating mutational burden. These outcomes may help identify the best candidates for tested combinations in the future.

Being tested
Atezolizumab + Ipatasertib, Atezolizumab + Bevacizumab
Keywords
Atezolizumab, Bevacizumab, Ipatasertib, Gastric adenocarcinoma, Umbrella phase 2 trial, Genomic landscape, Personalized Immunotherapy
Medical subject headings
Stomach Neoplasms, Adenocarcinoma

What participants receive

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

  • Atezolizumab + IpatasertibDrug

    Atezolizumab IV (1200 mg on day 1 of each 21-day cycle) and Ipatasertib PO (400 mg per day continuously, starting on cycle 1 day 1). Treatment given until disease progression or unacceptable toxicity.

  • Atezolizumab + BevacizumabDrug

    Atezolizumab IV (1200 mg on day 1 of each 21-day cycle) and Bevacizumab IV (15 mg/kg on day 1 of each 21-day cycle). Treatment given until disease progression or unacceptable toxicity.

Study groups in NCT04739202
Study groupRoleWhat they receive
Patients with tumors positive for EBV or microsatellite instable tumors (group 1)ExperimentalAtezolizumab IV (1200 mg every 3 weeks) + Ipatasertib tablet (400 mg a day continuously).
Receives: Drug: Atezolizumab + Ipatasertib
Patients with genomically stable tumors (group 2)ExperimentalAtezolizumab IV (1200 mg every 3 weeks) + Bevacizumab IV (15 mg/kg every 3 weeks).
Receives: Drug: Atezolizumab + Bevacizumab
Patients with tumors with chromosomal instability (group 3)ExperimentalAtezolizumab IV (1200 mg every 3 weeks) + Bevacizumab IV (15 mg/kg every 3 weeks).
Receives: Drug: Atezolizumab + Bevacizumab

What is being measured

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

  1. Objective response rate

    Objective response rate, using iRECIST, defined as the percentage of patients experiencing a complete response or a partial response, as their best tumor responses during the whole treatment period

    Measured: Through the expected duration of the treatment, an average of 27 weeks and a maximum of 2 years (estimated)

Secondary outcomes (3)

  1. Overall survival

    The overall survival (OS) will be measured from the date of inclusion to the date of death or to the end of the study or in a complementary study (to collect vital status and date of death, every 3 months for 5 years for patients alive at the end of the study).

    Measured: From the date of inclusion (Day -28 to Day 0) to the date of death or to the end of the study or in a complementary study (to collect vital status and date of death, every 3 months for 5 years for patients alive at the end of the study

  2. Progression-free survival

    The progression-free survival (PFS) will be evaluated according to iRECIST criteria.

    Measured: From the date of inclusion (Day -28 to Day 0) to the date of disease progression, or death or to the end of the study up to 52.5 months

  3. Safety, treatment-related adverse events

    Treatment-related adverse events are defined as the nature, number and grade of adverse events observed throughout the study and assessed using NCI-CTCAE v.5.0 criteria.

    Measured: 100 days after the last experimental treatment

Timeline

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

  1. First posted4 Feb 2021
  2. Study start19 Mar 2021
  3. Primary completion4 Jun 2026
  4. Study completion4 Jun 2026

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739202
Sponsor's protocol ID
69HCL19_0153
Other IDs
2020-000297-17
Acronym
IMMUNOGAST
Status last verified
Jun 2026
First submitted
13 Jan 2021
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab + Ipatasertib and Atezolizumab + Bevacizumab in people with Gastric Adenocarcinoma and Metastatic Gastric Cancer, run by Hospices Civils de Lyon at 8 sites in France.

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 21 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Through the expected duration of the treatment, an average of 27 weeks and a maximum of 2 years (estimated)). 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 NCT04739202.

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 Jun 2026.

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