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Anal Cancer MetastaticPhase 1/2GOBLETNCT07280377

A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab

A Phase 1/2 study testing Pelareorep, Atezolizumab and Gemcitabine and nab-paclitaxel in people with Anal Cancer Metastatic and Squamous Cell Carcinoma of the Anus Stage Unspecified, run by Oncolytics Biotech at 15 sites in Germany.

Active, not recruiting

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

Official record
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Trial summary

This is an open-label, phase 1/2, multiple-indication platform study to explore safety, potential predictive immune-related biomarkers, and early efficacy (as measured by objective response rate [ORR; Cohorts 1,2, 4,and 5] and disease control rate [DCR; Cohort 3]) in patients with advanced or metastatic… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pelareorep, Atezolizumab and Gemcitabine and nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
15 sitesGermany
Study dates
27 Oct 2021to 31 Dec 2028
Phase
Phase 1/2
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

None listed.

Who cannot join

  • Undergone systemic chemotherapy, radiotherapy, or surgery, <4 weeks before study treatment.
  • Received previous treatment with immune checkpoint inhibitors
  • Uncontrolled or severe cardiac disease
  • Active, uncontrolled infections
  • Symptomatic brain metastasis
  • Interstitial lung disease with symptoms or signs of activity.
Show all 19Show fewer
  • Autoimmune disease that has required systemic treatment in the past 2 years with disease modifying agents, corticosteroids, or immunosuppressive drugs.
  • A seizure disorder that requires pharmacotherapy.
  • Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
  • A non-healing wound, non-healing ulcer, or non-healing bone fracture within 4 weeks prior to the start of study drug.
  • Women who are pregnant or breastfeeding.
  • A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy
  • Any vaccine within 28 days prior to first treatment or during the first cycle of study treatment.
  • In Cohort 1, 2, 3, 4: Life expectancy less than 3 months
  • In Cohort 1, 2, 3: known active Hepatitis B (HBV) or Hepatitis C (HCV) infection that requires anti-viral treatment.
  • In Cohort 4: Prior HIV infection if the CD4+ T cell is <300 cells/µl
  • In Cohort 5: Known low or absent dihydropyrimidine dehydrogenase (DPD) activity.
  • In Cohort 5: Known leptomeningeal disease.
  • In Cohort 5: History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Germany15 sites

  • Gemeinschaftspraxis Dr. Med Bernhard Heinreich

    Augsburg, Bavaria, 86150

  • Charité Universitätsklinikum Berlin

    Berlin, State of Berlin, 13353

  • St. Josef-Hospìtal, Bochum

    Bochum, North Rhine-Westphalia, 44791

  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony, 09116

  • Krankenhaus Nordwest

    Frankfurt am Main, Hesse, 60488

  • Hämatologisch-Onkologische Praxis Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20249

  • Asklepios Kliniken Hamburg GmbH

    Hamburg, Free and Hanseatic City of Hamburg, 22763

  • Nationales Centrum für Tumorerkrankungen Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, Baden-Wurttemberg, 74078

  • Universität Leipzig

    Leipzig, Saxony, 04103

  • Universitätsmedizin Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Klinikum der Universität München

    München, Bavaria, 81377

  • Caritasklinikum Saarbrücken St. Theresia

    Saarbrücken, Saarland, 66113

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

About this study

Official title: A Phase 1 / 2 Multiple-indication Biomarker, Safety, and Efficacy Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab

This is an open-label, phase 1/2, multiple-indication platform study to explore safety, potential predictive immune-related biomarkers, and early efficacy (as measured by objective response rate [ORR; Cohorts 1,2, 4,and 5] and disease control rate [DCR; Cohort 3]) in patients with advanced or metastatic gastrointestinal (GI) tumors. Cohorts 1-4 are not randomized; however, Cohort 5 is comprised of two treatment arms to which patients are randomized in a 1:1 ratio.

Read the detailed description

The overall aim is to assess safety, predictive biomarkers, and preliminary efficacy as assessed by tumor response criteria at week 16 for cohorts1, 2, 3, and 4, and best overall response rate and OS in Cohort 5. If a cohort shows a promising ORR in Stage 1 of the Simon two-stage design, that cohort may be expanded to enroll additional patients (up to 50 patients in Cohorts 1 and 3 , up to 28 patients in Cohort 4, and up to 64 patients in Cohort 5) in an extension phase per predetermined statistical conditions. In addition, either or both arms of Cohort 5 may expand if the data collected in Stage 1 suggest that expansion may help in assessing the potential survival benefit of the investigational therapy(ies). In this study, we hypothesize that treatment with pelareorep will prime the tumor microenvironment (TME) for checkpoint blockade therapy, thereby increasing PD-L1 expression and the number of new T cell clones within the tumor, both of which are associated with increased response to checkpoint blockade.

Being tested
Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel, Trifluridine Tipiracil, mFOLFIRINOX Treatment Regimen

What participants receive

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

  • PelareorepDrug

    Pelareorep 4.5 x 10^10 TCID50 via 1-hour IV infusion

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab 840 mg IV infusion

  • Gemcitabine and nab-paclitaxelDrug

    Also called Gemzar, Abraxane

    Gemcitabine (1,000 mg/m2) and nab-paclitaxel (125 mg/m2)

  • Trifluridine TipiracilDrug

    Also called Lonsurf

    Trifluridine/tipiracil administered at a 35 mg/m2 dose orally twice daily

  • mFOLFIRINOX Treatment RegimenDrug

    mFOLFIRINOX- IV oxaliplatin 85 mg/m2; IV leucovorin 400 mg/m2; IV irinotecan 150 mg/m2; 5-FU 2400 mg/m2 by 46-hour infusion, per local standard of care

Study groups in NCT07280377
Study groupRoleWhat they receive
Cohort 1: Metastatic Pancreatic Cancer 1LExperimentalPatients with first-line (1L) locally advanced/metastatic unresectable pancreatic ductal adenocarcinoma (PDAC): Pelareorep and atezolizumab added to gemcitabine and nab-paclitaxel
Receives: Drug: Pelareorep; Drug: Atezolizumab; Drug: Gemcitabine and nab-paclitaxel
Cohort 2: Metastatic Colorectal Cancer 1L (MSI-H/dMMR)ExperimentalPatients with 1L metastatic colorectal cancer (mCRC), limited to microsatellite instability-high (MSIH) or mismatch repair deficient (dMMR) tumors: Pelareorep and atezolizumab
Receives: Drug: Pelareorep; Drug: Atezolizumab
Cohort 3: Metastatic Colorectal Cancer 3LExperimentalPatients with third-line (3L) mCRC independent of microsatellite instability (MSI)/dMMR status: Pelareorep and atezolizumab added to trifluridine/tipiracil
Receives: Drug: Pelareorep; Drug: Atezolizumab; Drug: Trifluridine Tipiracil
Cohort 4: Metastatic Unresectable Anal Cancer >/=2LExperimentalPatients with >/= 2L locally advanced/metastatic unresectable squamous cell carcinoma of the anal canal (SCCA) of viral or non-viral origin after prior systemic chemotherapy: Pelareorep and atezolizumab
Receives: Drug: Pelareorep; Drug: Atezolizumab
Cohort 5: Metastatic PDAC 1LExperimentalPatients with 1L metastatic PDAC: Pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab
Receives: Drug: Pelareorep; Drug: Atezolizumab; Drug: mFOLFIRINOX Treatment Regimen

What is being measured

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

  1. Overall Response Rate (ORR) for Cohort 1, 2, 4, and 5

    Proportion of patients with complete response [CR], partial response [PR] assessed by the investigators and/or central reader according to RECIST v1.1

    Measured: At week 16 (within each cohort)

  2. Disease Control Rate (DCR) - Cohort 3

    DCR (complete response [CR], partial response [PR], and stable disease [SD]) assessed by the investigators according to RECIST v 1.1.

    Measured: at week 16

  3. Overall Survival (OS) - Cohort 5

    OS is defined as the time from date of first treatment to death from any cause

    Measured: Cohort 5: From the date of randomization through long term follow up at 2 years

Secondary outcomes (5)

  1. Progression Free Survival (PFS)

    Time from the first dose date of study treatment to the date of investigator-determined objective progression (according to RECIST 1.1) or death from any cause, whichever occurs first.

    Measured: From initiation of treatment to objective progression or death from any cause, whichever occurs first, up to two years

  2. Duration of Response (DOR)

    Time from documentation of the first CR or PR to the time of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death.

    Measured: From initiation of treatment to disease progression or death from any cause, whichever occurs first, up to two years

  3. Disease Control Rate (DCR)

    Overall DCR, defined as the number of patients with a best overall response of CR, PR, or SD according to RECIST v. 1.1.

    Measured: From initiation of treatment to disease progression or death from any cause, whichever occurs first, up to two years

  4. Overall Response Rate (ORR) - Cohort 1-4

    ORR, defined as the percentage of patients with a best overall response of complete response [CR] or partial response [PR] according to RECIST v 1.1, and confirmed ORR, defined as the percentage of patients with a CR or PR at two or more consecutive evaluation timepoints.

    Measured: From initiation of treatment to disease progression or death from any cause, whichever occurs first, up to two years

  5. Overall Survival (OS) - Cohort 1-4

    OS defined as the time from date of first treatment to death from any cause

    Measured: From the date of randomization through long term follow up at 3 years

Timeline

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

  1. First posted12 Dec 2025
  2. Study start27 Oct 2021
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07280377
Sponsor's protocol ID
REO 029
Other IDs
2024-515936-62-00, 2020-003996-16
Acronym
GOBLET
Status last verified
May 2026
First submitted
18 Nov 2025
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pelareorep, Atezolizumab and Gemcitabine and nab-paclitaxel in people with Anal Cancer Metastatic and Squamous Cell Carcinoma of the Anus Stage Unspecified, run by Oncolytics Biotech at 15 sites in Germany.

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 0 inclusion and 19 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Overall Response Rate (ORR) for Cohort 1, 2, 4, and 5 (time frame: At week 16 (within each cohort)). The study lists 3 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 NCT07280377.

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 19 May 2026.

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