Improving Public Cancer Care by Implementing Precision Medicine in Norway

NCT04817956 | Recruiting Phase 2 DMC

• 1 other identifier: IMPRESS-Norway
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 17

Brief 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. 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.

Conditions

Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• 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.

  16 weeks

• Access to drugs for patients

  To evaluate percentage of patients included in treatment cohorts

  4 years

Secondary Outcomes (4)

• Progression free survival of patients starting treatment in the study

  4 years

• Overall survival of patients starting treatment in the study

  4 years

• Biomarker analyses

  4 years

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

  4 years

Study Arms (20)

Atezolizumab

EXPERIMENTAL

Atezolizumab used outside of current indication, based on biomarkers

Drug: Atezolizumab

Atezilizumab combined with bevacizumab

EXPERIMENTAL

Atezilizumab combined with bevacizumab used outside of indication, based on biomarkers

Drug: Atezolizumab

Phesgo (trastuzumab og pertuzumab)

EXPERIMENTAL

Phesgo used outside of indication, based on biomarkers.

Drug: Atezolizumab

Alectinib

EXPERIMENTAL

Alectinib used outside of indication, based on biomarker

Drug: Atezolizumab

vismodegib

EXPERIMENTAL

vismodegib used outside of indication, based on biomarker

Drug: Atezolizumab

entrectinib

EXPERIMENTAL

entrectinib used outside of indication, based on biomarker

Drug: Atezolizumab

Zelboraf + Cotellic

EXPERIMENTAL

Zelboraf + Cotellic used outside of indication, based on biomarker

Drug: Atezolizumab

Alpelisib

EXPERIMENTAL

Alpelisib used outside of indication, based on biomarker

Drug: Atezolizumab

Dabrafenib + trametinib

EXPERIMENTAL

Used outside of indication, based on biomarker

Drug: Atezolizumab

Melfalan

EXPERIMENTAL

Melfalan used outside ofcurrent indication

Drug: Atezolizumab

Pemazyre

EXPERIMENTAL

Pemazyre used outside ofcurrent indication

Drug: Atezolizumab

Selpercatinib

EXPERIMENTAL

used outside ofcurrent indication

Drug: Atezolizumab

Olaparib

EXPERIMENTAL

Used outside of current indication, for patients with bi-allelic BRCA-inactication

Drug: Atezolizumab

Capmatinib

EXPERIMENTAL

Used outside of current indication,

Drug: Atezolizumab

Imatinib

EXPERIMENTAL

Used outside of current indication,

Drug: Atezolizumab

Bortezomib

EXPERIMENTAL

Used outside of current indication,

Drug: Atezolizumab

Actinomycin D

EXPERIMENTAL

Used outside of current indication,

Drug: Atezolizumab

Niraparib

EXPERIMENTAL

Used outside of current indication,

Drug: Atezolizumab

Dostarlimab

EXPERIMENTAL

Used outside of current indication

Drug: Atezolizumab

Ceritinib

EXPERIMENTAL

Used outside of current indication

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

drugs used outside indication, based on biomarker

Also known as: Atezolizumab combined with bevacizumab, Phesgo (trastuzumab og pertuzumab), Alectinib, vismodegib, entrectinib, Vemurafenib and cobemitinib, Niraparib, Dostarlimab, Ceritinib

Actinomycin D; Alectinib; Alpelisib; Atezilizumab combined with bevacizumab; Atezolizumab; Bortezomib; Capmatinib; Ceritinib; Dabrafenib + trametinib; Dostarlimab; Imatinib; Melfalan; Niraparib; Olaparib; Pemazyre; Phesgo (trastuzumab og pertuzumab); Selpercatinib; Zelboraf + Cotellic; entrectinib; vismodegib

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Absolute neutrophil count ≥ 1.5 x109 / L
• 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).
• 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.
• 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.
• Medical Conditions

Sponsors & Collaborators

• Oslo University Hospital: lead
• Haukeland University Hospital: collaborator
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator
• University Hospital, Akershus: collaborator
• Vestre Viken Hospital Trust: collaborator
• Hospital of Southern Norway Trust: collaborator
• Ostfold Hospital Trust: collaborator
• The Hospital of Vestfold: collaborator
• Helse Stavanger HF: collaborator
• Nordlandssykehuset HF: collaborator
• Sykehuset Innlandet HF: collaborator
• Helse Forde: collaborator
• Helse Fonna: collaborator
• Helse Nord-Trøndelag HF: collaborator
• Helse Møre og Romsdal HF: collaborator
• Sykehuset Telemark: collaborator
• Lovisenberg Diakonale Hospital: collaborator

Study Sites (17)

Sykehuset Ålesund

Ålesund, Norway

NOT YET RECRUITING

Haukeland universitetssykehus

Bergen, Norway

RECRUITING

Nordlandssykehuset

Bodø, Norway

RECRUITING

Vestre Viken Hospital

Drammen, Norway

RECRUITING

Førde Hospital

Førde, Norway

RECRUITING

Sykehuset Innlandet

Hamar, Norway

RECRUITING

Helse Fonna

Haugesund, Norway

NOT YET RECRUITING

Sørlandet sykehus

Kristiansand, Norway

RECRUITING

Sykehuset Levanger

Levanger, Norway

NOT YET RECRUITING

Oslo University Hospital

Oslo, 0379, Norway

RECRUITING

Ahus

Oslo, Norway

RECRUITING

Sykehuset Telemark

Skien, Norway

RECRUITING

Stavanger universitetssykehus

Stavanger, Norway

RECRUITING

Universitetssykehuset i Nord-Norge

Tromsø, Norway

RECRUITING

St Olavs Hospital

Trondheim, 2381, Norway

RECRUITING

Sykehuset Vestfold

Tønsberg, Norway

NOT YET RECRUITING

Sykehuset Østfold Kalnes

Fredrikstad, Østfold fylke, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 35568909 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

atezolizumab; Bevacizumab; alectinib; HhAntag691; entrectinib; Vemurafenib; niraparib; dostarlimab; ceritinib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Åslaug Helland, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Åslaug Helland, MD PhD

CONTACT

+4722781364; ahelland@medisin.uio.no

Gro LIve Fagereng, PhD

CONTACT

22934000; gfageren@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Leader, Oncologist, Professor

Model Details: Simon 2-stage Basket-Umbrella

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 26, 2021
• Study Start: April 1, 2021
• Primary Completion (Estimated): March 30, 2040
• Study Completion (Estimated): April 30, 2045
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 4 years
• Access Criteria: academic interest

Locations

NO (17)