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Cancer MetastaticPhase 2IMPRESS-NNCT04817956

Improving Public Cancer Care by Implementing Precision Medicine in Norway

A Phase 2 study testing Atezolizumab in people with Cancer Metastatic, run by Oslo University Hospital at 17 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

IMPRESS-Norway is a prospective, non-randomized clinical trial evaluating efficacy of commercially available, anti-cancer drugs prescribed for patients with advanced cancer diagnosed with potentially actionable alterations as revealed by molecular diagnostics. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Cancer Metastatic
What is being tested?
Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
17 sitesNorway
Study dates
1 Apr 2021to 30 Apr 2045
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Type of Participant and Health status
  • Patient with a pathology-proven locally advanced or metastatic malignant disease who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated.
  • ECOG performance status 0-2.
  • For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
  • Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/exclusion criteria specified in the drug-specific study manuals for each agent will take precedence for this and all inclusion criteria (exceptions for haematological diagnoses):
  • Absolute neutrophil count ≥ 1.5 x109 / L
Show all 21Show fewer
  • Hemoglobin > 9 g/dl
  • Platelets > 75,000/µl
  • Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
  • AST (SGOT) and ALT(SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases)
  • Calculated or measured creatinine clearance ≥ 40 mL/min/1.73 m2.
  • Patients must have measurable or evaluable disease. RECIST v1.1 (10, 18) will be used for patients with solid tumours. For patients with multiple myeloma or non-Hodgkin lymphoma, IMWG response criteria (19) and CHESON/Lugano guidelines (20) will be used, resp. For glioblastoma patients, RANO criteria will be used (21). iRECIST will be used for immunotherapy-cohorts. IWG response criteria will be used for haematological cancers.
  • Patients whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumour marker only) are NOT eligible, with the exception of CA-125 for ovarian cancer and PSA for prostate cancer (22).
  • Results must be available from a genomic / molecular test performed in a preapproved laboratory (Section 10.15). The test used to qualify a patient for participation in IMPRESS-Norway may have been performed on any specimen of the patient's tumour obtained at any point during the patient's care at the discretion of the patient's treating physician. Genomic assays performed on cell-free DNA in plasma ("liquid biopsies") will also be acceptable if the genomic analysis is performed as defined in Section 10.5. NGS analyses will be performed on a newly sampled biopsy if possible. Information from these analyses might be used upon progression, for evaluation of possible new cohort-inclusion.
  • Have a genomic profile for which treatment with one of the approved targeted anti-cancer therapies included in this study has potential clinical benefit see Section 4.3.5
  • Note: Eligible genomic tests may include any of the following technologies and equivalent techniques: Immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR) (incl nanostring), array-based copy number analysis (CNV), sanger sequencing (SS), RNA sequencing, gene panels or whole exome sequencing (WES) by next generation sequencing (NGS). The test may have been performed on a fresh (frozen or in RNA-later) or paraffin-embedded specimen of the primary tumour or a metastatic deposit or on cell-free DNA derived from liquid biopsies (like for instance peripheral blood plasma), as determined by the treating physician, and must reveal a potentially actionable genomic variant or protein overexpression as defined in Section 4.3.
  • Patients must meet drug-specific eligibility requirements for the drug selected by the investigator.
  • Sex and Contraceptive/Barrier Requirements 9.8. Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate highly effective methods of contraception for the duration of study participation, and for 4 to 24 months following completion of study therapy as defined in Section 11.4.
  • 10.9. Female participants must have a negative highly sensitive pregnancy test <1 month prior to inclusion.
  • 11.10. Male patients should avoid impregnating a female partner. Male study patients must agree to one of the following: practice effective barrier contraception as described under sec. 11.4 during the entire study treatment period and through a certain time after the last dose of study drug. Details are given in the "Drug specific amendment".
  • Informed Consent 12.11. Ability to understand and the willingness to sign a written informed consent/assent document as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Guardians / parents can act on behalf of children.

Who cannot join

  • A potential participant who meets any of the following criteria will be excluded from participation in this study (other exclusion criteria might apply for specific drugs).
  • Medical Conditions
  • Patients eligible to enter other ongoing trials which have to potential to benefit the patients equally or more than a IMPRESS-Norway cohort, and for whom access to the ongoing trials is manageable (taking geography into consideration).
  • Ongoing toxicity > CTCAE grade 2, other than peripheral neuropathy, related to anti-tumour treatment that was completed within 4 weeks prior to treatment initiation. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3.
  • Patients with known progressive brain metastases determined by serial imaging or declining neurologic function in the opinion of the treating physician. Patients with previously treated / stable brain metastases are eligible. Additional exclusion criteria specific for GBM patients:
  • Patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). EIAED are prohibited. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to randomization.
Show all 17Show fewer
  • Patients with the following pre-existing cardiac conditions, uncontrolled angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
  • Patients with left ventricular ejection fraction (LVEF) known to be < 40%.
  • Patients with stroke (including TIA) or acute myocardial infarction within 4 months before the first dose of study treatment
  • Patients with acute gastrointestinal bleeding within 1 month of start of treatment
  • Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, severe psychiatric illness situations, or anticipated or planned anti-cancer treatment or surgery.
  • Patients with known allergy/hypersensitivity to the study drug (active substance or to any of the excipients).
  • Prior/Concomitant Therapy 9. Previous treatment with the selected study drug for the same malignancy. 10. Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate cancer. These medications must have been started ≥ 1 month prior to enrolment on this study. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific exclusion criteria.
  • Diagnostic assessments 11. If the patient's tumour has a genomic variant known to confer resistance to an anti-cancer agent available in this study, the patient will not be eligible to receive that agent but will be eligible to receive other drugs available in this study if all inclusion and exclusion criteria are met for that drug.
  • Other Exclusions 12. Female patients who are pregnant or nursing 13. Patients who do not meet drug-specific eligibility requirements for the drug selected by the investigator
  • Note: For each drug included in this protocol, specific inclusion and exclusion criteria (based on the Summary of Product Characterics (SPC) or manufacturer's recommendations) may also apply. These can be found in the supplemental information about each agent included in the appendices. Drug-specific inclusion and exclusion criteria will take precedence over the general inclusion/exclusion criteria
  • -

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Åslaug Helland, MD PhD contact

+4722781364

ahelland@medisin.uio.no

Gro LIve Fagereng, PhD contact

22934000

gfageren@ous-hf.no

17 sites in 1 country

Norway17 sites, 17 recruiting

  • Sykehuset Ålesund

    Ålesund

    Jo-Åsmund Lund, jo-asmund.lund@ntnu.no

    Not yet recruiting

  • Haukeland universitetssykehus

    Bergen

    Line Bjørge, MD, Line.Bjorge@uib.no

    Recruiting

  • Nordlandssykehuset

    Bodø

    Astrid Dalhaug

    Astrid.Dalhaug@nordlandssykehuset.no

    Recruiting

  • Vestre Viken Hospital

    Drammen

    Odd Terje Brustugun, ot.brustugun@gmail.com

    Recruiting

  • Førde Hospital

    Førde

    Liv Jorunn Vassbotn, MD

    liv.jorunn.vassbotn@helse-bergen.no

    Recruiting

  • Sykehuset Østfold Kalnes

    Fredrikstad, Østfold fylke

    Andreas Stensvold, +4769860000, Andreas.Stensvold@so-hf.no

    Recruiting

  • Sykehuset Innlandet

    Hamar

    Daniel Heinrich, Daniel.Heinrich@sykehuset-innlandet.no

    Recruiting

  • Helse Fonna

    Haugesund

    Sverre Fluge, Sverre.fluge@helse-fonna.no

    Not yet recruiting

  • Sørlandet sykehus

    Kristiansand

    Marte Grønlie Cameron

    Marte.Gronlie.Cameron@sshf.no

    Recruiting

  • Sykehuset Levanger

    Levanger

    Olav Toai Duc Nguyen, olavtoai@gmail.com

    Not yet recruiting

  • Oslo University Hospital

    Oslo, 0379

    Geir Olav Hjortland, GOO@ous-hf.no

    Recruiting

  • Ahus

    Oslo

    Anne Hansen Ree, a.h.ree@medisin.uio.no

    Recruiting

  • Sykehuset Telemark

    Skien

    Dalia Dietzel, jada@sthf.no

    Recruiting

  • Stavanger universitetssykehus

    Stavanger

    Bjørnar Gilje, bjornar.gilje@sus.no

    Recruiting

  • Sykehuset Vestfold

    Tønsberg

    Karin Semb, karin.semb@siv.no

    Not yet recruiting

  • Universitetssykehuset i Nord-Norge

    Tromsø

    Egil Blix

    egil.blix@uit.no

    Recruiting

  • St Olavs Hospital

    Trondheim, 2381

    Åsmund Flobak, asmund.flobak@ntnu.no

    Recruiting

Other trials in Norway

About this study

Official title: Improving Public Cancer Care by Implementing Precision Medicine in Norway A Multi-cohort Phase 2 Treatment Clinical Study Investigating Efficacy of Approved Drugs Outside Indication in Patients With Advanced Cancer

IMPRESS-Norway is a prospective, non-randomized clinical trial evaluating efficacy of commercially available, anti-cancer drugs prescribed for patients with advanced cancer diagnosed with potentially actionable alterations as revealed by molecular diagnostics. IMPRESS-Norway is a nation-wide study and all hospitals with an oncology and / or hematology department will be invited to participate in the study. The study will use a combined umbrella and basket design and a Simon two-stage model of expanding cohorts to follow up potentially effective combinations of biomarker and drug on specific indications. Sampling of biological material will be performed at presentation, during treatment and upon progression. Additional biomarker and translational analyses including whole genome sequencing (WGS) on tumour material and liquid biopsies, identifying mechanisms underlying drug sensitivity versus resistance will be performed.

Read the detailed description

Eligible patients have an advanced malignancy already treated with standard treatment, acceptable performance status and organ function, with no other suitable clinical trial available in Norway. A molecular test performed at a study specific reference laboratory has identified a potentially targetable molecular profile. Next, a suitable drug should be available from the trial drug armamentarium. Finally, if the patient fulfils the inclusion criteria and is accepted for the trial, a second tumour biopsy (snap-frozen)/ tumour material for WGS will be sampled. Patients enrolled in the study will enter an existing cohort, or, in case a suitable cohort does not exist, a new cohort can be opened. One cohort will consist of one diagnostic subgroup, one drug (or one drug-combination) and one molecular marker. The choice of drug(s) will be supported by a list of potential profiles. In addition, available knowledge from the literature will be used to prepare discussion in a national molecular tumour board, which will provide a treatment recommendation to the treating physician and the study doctors . The protocol-specified treatment may be administered to the patient once drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future biomarker studies and research on responders versus non-responders.

All patients who receive treatment with a drug available in the protocol will be monitored for standard efficacy outcomes including tumour response, progression-free and overall survival as well as study specific measures as duration of treatment. Patients that are screened, but not included into any cohorts will be followed for 16 weeks for survival and clinical course of disease. Treatment-related toxicities (CTCAE grade 3-5) will be evaluated. Study-specific treatment and outcome data including results from the molecular screening will be reported to the Cancer Registry of Norway. Long-term follow up data using the Cancer Registry of Norway and information from The Norwegian Patient Registry, The Norwegian Prescription Database and Primary patient- and user Register (KPR) will be collected on all patients screened.

Being tested
Atezolizumab
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • AtezolizumabDrug

    Also called Atezolizumab combined with bevacizumab, Phesgo (trastuzumab og pertuzumab), Alectinib, vismodegib

    drugs used outside indication, based on biomarker

Study groups in NCT04817956
Study groupRoleWhat they receive
AtezolizumabExperimentalAtezolizumab used outside of current indication, based on biomarkers
Receives: Drug: Atezolizumab
Atezilizumab combined with bevacizumabExperimentalAtezilizumab combined with bevacizumab used outside of indication, based on biomarkers
Receives: Drug: Atezolizumab
Phesgo (trastuzumab og pertuzumab)ExperimentalPhesgo used outside of indication, based on biomarkers.
Receives: Drug: Atezolizumab
AlectinibExperimentalAlectinib used outside of indication, based on biomarker
Receives: Drug: Atezolizumab
vismodegibExperimentalvismodegib used outside of indication, based on biomarker
Receives: Drug: Atezolizumab
entrectinibExperimentalentrectinib used outside of indication, based on biomarker
Receives: Drug: Atezolizumab
Zelboraf + CotellicExperimentalZelboraf + Cotellic used outside of indication, based on biomarker
Receives: Drug: Atezolizumab
AlpelisibExperimentalAlpelisib used outside of indication, based on biomarker
Receives: Drug: Atezolizumab
Dabrafenib + trametinibExperimentalUsed outside of indication, based on biomarker
Receives: Drug: Atezolizumab
MelfalanExperimentalMelfalan used outside ofcurrent indication
Receives: Drug: Atezolizumab
PemazyreExperimentalPemazyre used outside ofcurrent indication
Receives: Drug: Atezolizumab
SelpercatinibExperimentalused outside ofcurrent indication
Receives: Drug: Atezolizumab
OlaparibExperimentalUsed outside of current indication, for patients with bi-allelic BRCA-inactication
Receives: Drug: Atezolizumab
CapmatinibExperimentalUsed outside of current indication,
Receives: Drug: Atezolizumab
ImatinibExperimentalUsed outside of current indication,
Receives: Drug: Atezolizumab
BortezomibExperimentalUsed outside of current indication,
Receives: Drug: Atezolizumab
Actinomycin DExperimentalUsed outside of current indication,
Receives: Drug: Atezolizumab
NiraparibExperimentalUsed outside of current indication,
Receives: Drug: Atezolizumab
DostarlimabExperimentalUsed outside of current indication
Receives: Drug: Atezolizumab
CeritinibExperimentalUsed outside of current indication
Receives: Drug: Atezolizumab

What is being measured

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

  1. 16 weeks clinical response

    To determine percentage of patients who have "not progression" on treatment. "Not progression" is complete response, partial response and stable disease.

    Measured: 16 weeks

  2. Access to drugs for patients

    To evaluate percentage of patients included in treatment cohorts

    Measured: 4 years

Secondary outcomes (4)

  1. Progression free survival of patients starting treatment in the study

    Progression-free survival

    Time from treatment initiation to progression of disease

    Measured: 4 years

  2. Overall survival of patients starting treatment in the study

    Time from treatment initiation to death Duration of time on drug Time from the molecular diagnostics first informed consent to starting treatment

    Measured: 4 years

  3. Biomarker analyses

    • Estimate the percentage of patients eligible for analyses only by liquid biopsies

    Measured: 4 years

  4. • Access of tumour tissue biopsy across and within tumour types

    • Number of tumour / molecular assessments per patient / cohort

    Measured: 4 years

Timeline

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

  1. First posted26 Mar 2021
  2. Study start1 Apr 2021
  3. Primary completion30 Mar 2040 (estimated)
  4. Study completion30 Apr 2045 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Simon 2-stage Basket-Umbrella
Masking
None (open label)
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04817956
Sponsor's protocol ID
IMPRESS-Norway
Acronym
IMPRESS-N
Status last verified
Feb 2024
First submitted
19 Mar 2021
Last updated
29 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to publish results from the study, reporting on our predefined endoints

Publications

  • Helland A, Russnes HG, Fagereng GL, Al-Shibli K, Andersson Y, Berg T, Bjorge L, Blix E, Bjerkehagen B, Brabrand S, Cameron MG, Dalhaug A, Dietzel D, Donnem T, Enerly E, Flobak A, Fluge S, Gilje B, Gjertsen BT, Gronberg BH, Gronas K, Guren T, Hamre H, Haug A, Heinrich D, Hjortland GO, Hovig E, Hovland R, Iversen AC, Janssen E, Kyte JA, von der Lippe Gythfeldt H, Lothe R, Lund JA, Meza-Zepeda L, Munthe-Kaas MC, Nguyen OTD, Niehusmann P, Nilsen H, Puco K, Ree AH, Riste TB, Semb K, Steinskog ESS, Stensvold A, Suhrke P, Tennoe O, Tjonnfjord GE, Vassbotn LJ, Aas E, Aasebo K, Tasken K, Smeland S. Improving public cancer care by implementing precision medicine in Norway: IMPRESS-Norway. J Transl Med. 2022 May 14;20(1):225. doi: 10.1186/s12967-022-03432-5.

    PubMed 35568909

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab in people with Cancer Metastatic, run by Oslo University Hospital at 17 sites in Norway.

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

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Åslaug Helland, MD PhD (+4722781364, ahelland@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

16 weeks clinical response (time frame: 16 weeks). 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 NCT04817956, which also lists 1 linked publication.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.

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