Study history

Studies started at Oslo University Hospital with involvement from Department of Clinical Cancer Research (Seksjon for utprøvende kreftbehandling)

STUDIES STARTED IN 2021: DIAGNOSIS

SPONSOR 

PHASE CLINICAL TRIALS
CORINTH: Phase 1B/II Trial of checkpointinhibitor(Pemborlizumab and anti PD-1 antibody) plus standard IMRT in HPV induced stage III Squamous Cell Carsinoma (SCC) of Anus Anal  Cardiff university Phase I/II  
CA017-078: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant Chemotherapy plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post-Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-In Bladder BMS Phase III  
MK7339-012: A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Adva Lung MSD Phase III  
CA022-001: En fase 1 / 2a studie av monoklonalt antistoff BMS-986218 som monoterapi og i kombinasjon med Nivolumab hos pasienter med avanserte solide tumorer. Melanoma BMS Phase I/II  
V937-013: A Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination with Pembrolizumab (MK-3475) in Participant with Advanced/Metastatic Solid Tumors Multiple diagnoses MSD Phase I/II  
NAVIGATE: En basket-studie i fase 2 av den orale TRK-hemmeren larotrectinib hos pasienter med NTRK-fusjonspositive tumorer   Bayer Phase II  
EPIK-B3: A Phase II, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple negative breast cancer with either phosphoinsi Mamma Novartis Phase III  
KO_TIP_007: The AIM-HN and SEQ-HN Study: A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Head and neck  KURA Oncology Phase III  
MK1454-002: A Phase 2 Study in First Line Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma to Evaluate Intratumoral MK-1454 in Combination with IV Pembrolizumab vs IV Pembrolizumab Monotherapy Head and neck  MSD Phase II  
INCB-54828-302 / Fight-302: A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarc Cholangiocarcinom Incyte Corporation Phase III  
Re-RAD-I: External beam radiotherapy for pelvic recurrences in rectal cancer patients previously treated with radiotherapy Colorectal   Phase II  
CANOPY-1: A randomized, double-A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab as first line therapy for locally advanced or me Lung Novartis Phase III  
UVEA-Brig: Use via expanded access to brigatinib Lung Takeda Pharmaceuticals International Reg  
ORCHARD: A Biomarker-Directed Phase 2 Platform Study in Patients with AdvancedA Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-Small Cell Lung Cancer whose Disease has Progressed on First-Line Osimertinib Therapy  Lung Astra Zeneca Phase II  
BLU-667-2303: A Randomized, Open-Label, Phase 3 Study of Pralsetinib versus Standard of Care for First Line Treatment of RET fusion-positive, Metastatic Non-Small Cell Lung Cancer Lung Blueprint Medicinese Corporation Phase III  
GSK-ZEAL-1: NSCLC 1 linje beh med PARP-hemmer og pembrolizumab, fase 3A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose D Lung GSK Phase III  
CLXH254C12201: En studie for å vurdere effekt og sikkerhet av flere kombinasjonsbehandlinger med LXH254 hos pasienter med tidligere behandlet ikke-operabel eller metastatisk melanom med BRAFV600 eller NRAS mutasjon Melanoma Novartis Phase II  
MCLA-128-CL01: A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors Multiple diagnoses Merus NV Phase I/II  
TALAPRO-2: A phase 3, randomized, double-blind, placebo-controlled study of talazoparib with enzalutamide in metastatic castration-resistant prostate cancer Prostata Pfizer Phase III  
TENDU-101: A First-in-Man, Open-label, Single center, Dose-selection Study of Safety and Effect of Different Doses of TENDU Vaccine, a Therapeutic Peptide Conjugate Vaccine, in Patients with Relapse after Primary Radical Prostatectomy Prostata Ultimovacs Phase I  
rEECur: International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma Sarcoma Euro Ewing Consortium Phase II/III  
STS: Sequential neoadjuvant ifosfamide and doxorubicin in localized high-grade soft tissue sarcoma of extremities and trunk wall Sarcoma Oslo university hospital Phase II  
NEC: Kliniske, radiologiske og molekylære karakteristika hos pasienter som behandles for gastroenteropankreatisk nevroendokrine svulster Esophagus Oslo university hospital Obs  
NeoRes 2: Randomized clinical trial comparing the timing of  resective surgery after neoadjuvant
chemoradiotherapy in cancer of the esophagus or gastric cardia
Esophagus Scandinavian Esophageal and Gastric Cancer Group Phase II  
NEEDS: NEoadjuvant Chemoradiotherapy for Esophageal squamous cell carcinoma versus Definitive chemoradiotherapy with salvage Surgery as needed Esophagus Karolinska university hospital Phase IV   
         
STUDIES STARTED IN 2020: DIAGNOSIS SPONSOR PHASE CLINICAL TRIALS
CA209-8HW: A Phase 2 Clinical Trial of Nivolumab Monotherapy in Previously Treated Recurrent or Metastatic Microsatellite Instability High (MSI-H) Colorectal Cancer Colorectal BMS Phase II  
BM7PE: A phase I/II study with BM7PE immnotoxin in colorectal cancer patients with metastatic disease who are refractory to or with intorerance to last line of standard chemotherapy Colorectal Oslo university hospital Phase I/II  
Bortem-17: Bortezomib sensitization of recurrent glioblastoma with unmethylated MGMT promoter to Temozolomide phase 1B/II study CNS Haukeland university hospital Phase I/II  
Tungespacerstudien: Pasientrapporterte utfall ved bruk av tungespacer under  strålebehandling av kreft i munnhule eller bihule Head and neck Oslo university hospital Phase II  
INDUCE-3: A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment Head and neck GSK Phase II  
EORTC 1707 VESTIGE: Adjuvant immunotherapy in patients with resected gastric cancer following preoperative chemotherapy with high risk for recurrence (N+ and/or R1): an open label randomized controlled phase-2-study (VESTIGE) Esophagus EORTC Phase II  
MK3475-867: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Medically Inoperable Stages I or IIA Non Small Cell Lung Can Lung MSD Phase III  
DART: Durvalumab (MEDI4736) After chemoRadioTherapy (DART) for NSCLC patients – a phase II translational and biomarker study investigating PDL1 positive and negative patients Lung Oslo university hospital Phase II  
NIPU: Nivolumab and ipilimumab +/- UV1 vaccination as second line treatment in patients with malignant mesothelioma Lung Oslo university hospital Phase II  
EORTC 1825-LCG: Acitivity of Lorlatinib  based on ALK resistance mutations on blood in ALK positive NSCLC patients previously treated with 2nd generation ALK inhibitor Lung EORTC Phase II  
BELINDA: Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial  Lymphoma Novartis Phase III  
AERN: Abscopal Effect of Radiotherapy and Nivolumab in anti-PD-1 Pretreated Relapsed or Refractory Hodgkin Lymphoma: An International Multicenter Phase II Trial Lymphoma University of Cologne Phase II  
Polar Bear: R-mini-CHOP versus R-mini-CHP in combination with polatuzumab-vedotin, as primary treatment for patients with diffus large B-cell lymphoma, =80 years, or frail =75 years - an open label randomized Nordic Lymphoma group phase III trial - NLG-LBC7  Lymphoma Lung university hospital Phase III  
UV1-202: A Randomized Phase II, Open-label, Active-controlled, Multicenter Study Investigating the Efficacy and Safety of UV1 Vaccination in Combination with Nivolumab and Ipilimumab as First-line Treatment of Patients with Unresectable or Metastatic Melanoma Melanoma Ultimovacs Phase II  
CA209-76K: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma Melanoma MSD Phase III  
V937-011: A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination with Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants with Advanced/Metastatic Melanoma Melanoma MSD Phase II  
ImPRESS: Imaging Perfusion Restrictions from Extracellular Solid Stress Multiple diagnoses Oslo university hospital Phase II  
Off-label study: Off-label use of anti-cancer drugs in Norway Multiple diagnoses Oslo university hospital Obs  
PACTO: A multinational, randomized, phase ii study of the combination of nab-paclitaxel and gemcitabine a multinational, randomized, phase ii study of the combination of nab-paclitaxel and gemcitabine with or without il-6r inhibitor, tocilizumab, as first-line treatment Pancreas Herlev and Gent hospital Phase II  
         
STUDIES STARTED IN 2019: DIAGNOSIS SPONSOR PHASE CLINICAL TRIALS
INCMGA 0012-202: A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy Anal  Incyte corporation Phase II  
PCI-A203-18: A multi-centre randomised open-label Phase II Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-induced Photochemical Internalisation (PCI) of Gemcitabine followed by Gemcitabine/Cisplatin Chemotherapy versus Gemcitabine/ Cisplatin alone Cholangiocarcinom PCI Biotech Phase II  
ICO-CC-005: An Open-label, Multiple-site, Phase I/II Dose Cohort Trial of [6R] 5,10-Methylene Tetrahydrofolate (Modufolin®) in Combination with a Fixed Dose of 5-Fluorouracil (5-FU) alone or together with a Fixed Dose of Oxaliplatin or Irinotecan in Patients with Stage IV Colorectal Cancer Colorectal Isofol Phase I/II  
PROTEOS: Protein intake in patients with colorectal or lung cancer during first line treatment with chemo(radio)- or immunotherapy when receiving a low volume, energy dense and high protein oral nutritional supplement: a randomised, controlled study Colorectal Nutrica Research  Phase IV  
METIMMOX: Colorectal cancer metastasis - Shaping anti-tumor immunity by Oxaliplatin Colorectal Akershus university hospital Phase II  
DIRECT: (DIsulfiram REsponse as add-on to ChemoTherapy in recurrent) Glioblastoma: A randomized controlled trial CNS Sahlgrenska university hospital Phase II  
CA224-060: A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (anti-LAG-3) plus Nivolumab in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy as First-Line Treatment in Patients with Gastric or Gastroesophageal Junction Ad Esophagus BMS Phase II  
INTENSE: Irinotecan-basert triplett (FOLFOXIRI) kjemoterapi som cellegift behandling før og etter operasjon for kreft i magesekken og overgang mellom spiserør og magesekken (INTENSE studie) Esophagus Skåne university hospital Phase II  
MK3475-630: A phase 3, randomized, double-blind, placebo-controlled study to evaluate Pembrolizumab versus placebo as a adjuvant therapy following surgery and radiation in participants with high-risk locally advanced cutaneous squamous cell carcinoma  Head and neck  MSD Phase III  
MK3475-937: A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and
Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants
with Hepatocellular Carcinoma and Complete Radiological Response after Surgical
Resection or Local Ab
Liver/bile duct MSD  Phase III  
FIOL: First-line treatment with osimertinib in EGFR-mutated non-small cell lung cancer, coupled to extensive translational studies (FIOL) Lung Vestre Viken Phase II  
ASTEROID: Ablative stereotactic Radiotherapy with Durvalumab (MEDI4736). An open label randomized phase 2 trial with durvalumab following stereotactc Body radiotherapy (SBRT) in patient with T1-2N0M0 Non-small Cell Lung Cancer (NSCLC). Lung Sahlgrenska university hospital Phase II  
NARLAL 2: Novel Approach to Radio Therapy in Locally Advanced Lung Cancer - Heterogeneous FDG-guided dose escalation with concomitant Navelbine Lung Odense university hospital Phase III  
CANOPY-A: A phase III, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of canakinumab versus placebo as aduvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected ( Lung Novartis Phase III  
ELARA: A phase II, single arm, multicenter open label trial to determine the efficacy and safety of tisagenlecleucel (CTL019) in adult patients with refractory or relapsed follicular lymphoma Lymphoma Novartis Phase III  
Lymrit-37-01: A phase I/II study of lutetium-lilotomab satetraxetan antibody-radionuclide-conjugate for treatment of relapsed non-Hodkin lymphoma Lymphoma Nordic Nanosector Phase I/II  
ONCOS C824: A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients with Advanced or Unresectable Melanoma Progressing after PD1 Blockade Melanoma Targovac Phase I  
Debio 1347-201: A Phase II basket study of the oral selective pan-FGFR inhibitor Debio 1347 in subjects with solid tumors harboring a fusion of FGFR1, FGFR2 or FGFR3 Multiple diagnoses Debiopharm Phase II  
MX39795 CUPISCO: A phase II trial comparing the efficacy and safety of targeted therapy or cancer immunotherapy guided by genomic profiling versus platinum-based chemotherapy in patients with CUP Origo inserta Roche Phase II  
D6070C00005: A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) with or without Durvalumab in Combination with Chemotherapy in Subjects with Metastatic Pancreatic Ductal Adenocarcinoma Pancreas Astra Zeneca Phase I/II  
STORM: A randomized phase II trial for the Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM) Prostata Gent university hospital Phase II  
SACRO: S+B10Acral Chordoma: a Randomized & Observational study on surgery versus definitive radiation therapy in primary localized disease Sarcoma Italian Sarcoma Group Obs  
INTRIGUE: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant Chemotherapy plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post-Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-In Sarcoma Deciphera Pharma ceuticals Phase III  
FAKT: Physically Active During Cancer Treatment Stomach St. Olavs Hospital  Other  
         
STUDIES STARTED IN 2018:  DIAGNOSIS SPONSOR PHASE CLINICAL TRIALS
ARRAY-818-302: Clonal evolution and prediction of response to (ARRAY) targeted therapy in patients with BRAF-mutant colorectal cancer.  Colorectal Array Biopharma Phase III  
TCR-CRC-001: T cell receptor based therapy of metastatic colorectal cancer with mRNA-engineered T cells targeting transforming growth factor beta receptor type II (TGFßII) Colorectal Oslo university hospital Phase I  
EORTC 1709: A phase III trial of marizomib in combination with standard temozolomide-based radiochemotherapy versus standard temozolomide-based radiochemotherapy alone in patients with newly diagnosed glioblastoma CNS EORTC Phase III  
DEN-STEM: Open label randomized phase II/III trial of dendritic cell immunotherapy against cancer stem cells in glioblastoma patients receiving standard therapy CNS Oslo university hospital Phase II/III  
CA209-9M9 (INEC): Safety and feasibility of irradiation and nivolumab in esophageal cancer Esophagus Oslo university hospital Phase I/II  
MK3475-629: A Phase 2, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) Head and neck  MSD Phase II  
DAHANCA30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC Head and neck  DAHANCA Phase III  
NTCP: Development and validation of NTCP (normal tissue complication probability) models for head and neck cancer Head and neck  Haukland university hospital Other  
BGBC008: A Phase II, Multi-Centre Study of BGB324 in Combination with Pembrolizumab in Patients with Previously Treated Advanced Adenocarcinoma of the Lung Lung BerGenBio Phase II  
ICI: The new check point inhibitors – identification of predictive biomarkers in lung cancer Lung Oslo university hospital Obs.  
COM-IT 1: Combinatory ImmunoTherapy-1 (Com-IT-1) Irradiation and PDL-1 blockade in locally advanced / advanced NSCLC Lung Oslo university hospital Phase II  
Achiles: A randomized phase II study comparing atezolizumab after concurrent chemoradiotherapy with chemoradiotherapy alone in limited disease small-cell lung cancer Lung NTNU Phase II  
HD-21: Treatment optimization trail in the first-line treatment of advanced stage Hodkin lymphoma; comparison of 4-6 cycles of escalated BEACOPP with 4-6 cycles of BrECADD Lymfoma University of Cologne Phase III  
P(R)EBEN: A Phase I/II study of the combination of pixantrone, etopside, bendamustine and, in CD-20 positive tumors, rituximab in patients with relapsed aggressive non-Hodkin lymphomas of B- or T-cell phenotype - The P(R)EBEN study Lymfoma Århus university hospital Phase I/II  
Bio-CHIC: BIOmarker driven dose intensified CHemoImmunotherapy with early CNS prophylaxis Lymfoma Helsinski university hospital Phase II  
MATRix/IELSG43: High-dose chemotherapy and autologous stem cell transplant or consolidating conventional chemotherapy in primary CNS lymphoma - randomized phase III trial Lymfoma University of Stuttgard Phase III  
ENRICH: Randomised, open label study of rituximab / Ibrutinib vs Rituximab / Chemotherapy in older patients with untreated mantle cell lymphoma Lymfoma Plymouth Hospitals NHS Trust Phase II/III  
VALERIA: Venetolax, lenalidomide and rituximab in patients with relapsed / refractory mantle cell lymphoma  Lymfoma Nordic Lymphoma Group Phase I/II  
Archer-1: A phase 1b open-label study of Betalutin in combination with rituximab in patients with relapsed/refractory follicular lymphoma  Lymfoma Nordic Nanovector Phase I/II  
ICON CA209-9FN: A randomized phase IIb study evaluating immunogenic chemotherapy combined with ipilimumab and nivolumab in patients with metastatic hormone reseptor positive breast cancer Mamma Oslo university hospital Phase II NCT03409198
EMIT-1: Establishment of Molecular profiling for Individual clinical routine Treatment decision in Early Breast Cancer (EMITEBC-1) Mamma Oslo university hospital Phase II  
OPTIMA: Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis Mamma University College London Phase III  
COMBI-I: A randomized, double-blind, placebo-controlled, phase III study comparing the combination of PDR001, dabrafenib and trametinib versus placebo, dabrafenib and trametinib in previously untreated patients with unresectable or metastatic BRAF V600 mutant melanoma Melanoma Novatis Phase III  
CLXS196X2101: A Phase I, multi-center, open-label, study of LXS196, an oral protein kinase C inhibitor, in patients with metastatic uveal melanoma Melanoma Novatis Phase I  
COMBI-APlus: Open-label, phase IIIb study of dabrafenib in COMBInation with trametinib in the Adjuvant treatment of stage III BRAF V600 mutation-positive melanoma after  complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-man Melanoma Novatis Phase III  
CA224-047: A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Metastatic or Unresectable Melanoma Melanoma BMS Phase II/III  
CA017-003: A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab (anti-PD-1 Monoclonal Antibody) and in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors Multiple diagnoses BMS Phase I/II  
MK3475-587: A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial. Multiple diagnoses MSD Phase III  

 

Updated 12 may 2021