Kliniska studier vid Tema Cancer

–Studier öppna för inklusion inom PO Huvud-, Hals-, Lung- och Hudcancer–

Här visas de studier som är öppna för patientinklusion inom den medicinska enheten (ME). Studierna är uppdelade på de olika patientflödena. Vidare visas ansvarig prövare, forskningssjuksköterska och planerad och aktuell inklusion inom temat (visas ej utanför Karolinska). Listan uppdateras minst en gång i veckan. -Längst ner finns en förklaring till de olika kolumnerna.

Hudtumörer

 Nr Namn

Fas

Startdatum Ansvarig prövare

16/34

TRIM. TRIM study protocol - a prospective randomized multicenter Trial to assess the Role of Imaging during follow up after radical surgery of stage IIb-c and III cutaneous malignant Melanoma.

3

2017-06-08

Hildur Helgadottir

17/414

Studie immunologisk aktivitet hos melanomtumörer. Studier av immunologisk aktivitet hos melanomtumörer som opereras bort

Ej tillämpbar

2021-10-18

Hildur Helgadottir

20/036

PROMMEL. Precision Radiation of Immune Checkpoint Therapy Resistant Melanoma Metastases

2

2021-03-08

Hildur Helgadottir

21/106

Bio-Melanom. En provsamlingsstudie för att identifiera biomarkörer av betydelse för behandlingseffekt och toxicitet vid medicinsk behandling av patienter med malignt melanom

Ej tillämpbar

2022-08-15

Fernanda Costas Svedman

22/076

Melbank-studien. Studier på primära melanom och högrisk sjukdom.

Ej tillämpbar

2023-06-19

Hanna Eriksson

24/006

PRISM-MEL-301. A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)

3

2024-10-10

Hanna Eriksson

24/040

SCANDIUM III. A Phase III Randomized Controlled Multicentre Trial of Percutaneous Hepatic Perfusion in Combination with Ipilimumab and Nivolumab Compared to Ipilimumab and Nivolumab Only in Patients with Uveal Melanoma Liver Metastases – the SCANDIUM III trial

3

2024-10-24

Hildur Helgadottir

24/081

GRAND-SLAM. A prospective randomized international multicenter study to compare Short versus Long Adjuvant immunotherapy after radical surgery of stage IIb-c, III and IV cutaneous malignant Melanoma

3

2025-02-17

Hildur Helgadottir

Lungcancer

 Nr Namn

Fas

Startdatum Ansvarig prövare

18/054

Immu-LC-studien. Det immunologiska landskapet- lungcancer, The immunological landscape in lung cancer. Studies of effector mechanisms and biomarkers in patients with NCLC undergoing treatment with checkpoint inhibitors

Ej tillämpbar

2021-10-25

Luigi De Petris

19/089

PreDDLung-studien tid Biobank-Lung. Uppbyggnad av biobank för lungcancerforskning vid Karolinska Universitetssjukhuset

Ej tillämpbar

2021-05-10

Simon Ekman

21/025

MO41552-ROS 1. A randomised, open label, multicentre, phase 3 study of entrectinib versus crizotinib in patients with locally-advanced or metastatic non-small cell lung cancer harbouring ROS1 gene rearrangements with and without central nervous system metastases

3

2022-03-30

Georgios Tsakonas

21/065

ASAB. ASAB - Alectinib followed by concomitant consolidation SBRT/hypofractionated radiation therapy in advanced NSCLC with ALK-rearrangement

1

2022-12-13

Karin Lindberg

21/070

M18-868-Teliso. Phase 3, open-label, randomized, controlled, global study in subjects with c-Met overexpressing (c- Met+), EGFR wildtype, locally advanced/metastatic non-squamous NSCLC that has progressed after standard of care therapy.

3

2023-02-20

Georgios Tsakonas

22/003

SOLUCOM. Sotorasib in advanced KRASG12C -mutated non-small cell lung cancer patients with comorbidities (SOLUCOM)

2

2024-10-28

Simon Ekman

22/004

PROTHYM. Phase II non-randomized study on Proton Radiotherapy Of Thymic Malignancies

2

2022-04-19

Karin Lindberg

22/006

LUCA-S. Web-based symptom monitoring and survival in advanced stage lung cancer

3

2022-12-01

Gunnar Wagenius

22/026

BO42777 HORIZON01. A phase 1-3, multicenter study evaluating the efficacy and safety of multiple therapies in cohorts of patients selected according to biomarker status, with locally advanced, unresectable, stage III non-small cell lung cancer

3

2023-12-20

Georgios Tsakonas

22/033

TRIPLEX. Randomized phase III trial investigating the survival benefit of adding thoracic radiotherapy (TRT) to durvalumab immunotherapy plus chemotherapy in extensive stage small-cell lung cancer

3

2023-04-06

Luigi De Petris

22/051

EFS-Frailty in lung cancer. Frailty among elderly patients with advanced lung cancer

Ej tillämpbar

2024-02-29

Jeanette Winterling

22/056

KSAB. Sotorasib followed by SBRT to 1-3 lesions in advanced NSCLC with KRASG12C mutation

1

2023-06-20

Karin Lindberg

23/017

ANDROMEDA. Addition of hypofractionated high dose radiation in oligometastatic disease - An open label randomized phase III trial comparing up-front radiation in oligometastatic non-small cell lung cancer (NSCLC) and systemic treatment with systemic treatment alone

3

2024-02-06

Karin Lindberg

23/031

ERIS. EGFR-mutated lung cancer in randomized investigator initiated study. ERIS is a national, randomized phase III trial for advanced NSCLC harboring targetable EGFRmutations.The trial is academic and initiated by Swedish Lung Cancer Study Group (SLUSG). Patients will be randomized to third generation EGFR-inhibitor ( osimertinib) or second-generation EGFR-inhibitor (investigator's choice between afatinib and dacomitinib). Primary endpoint is PFS. Series of exploratory molecular analyses are planned on repeatedl

3

2023-09-18

Simon Ekman

23/046

Bridge D9106C00002. A multicentre, Phase II, single-arm, interventional study of neoadjuvant durvalumab and platinum-based chemotherapy (CT), followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab, in participants with resectable or borderline resectable stage IIB-IIIB Non-small Cell Lung Cancer (NSCLC)

2

2024-08-15

Karin Lindberg

23/078

MARS. Multicentre phase III study: Addition of Radiotherapy to Standard chemotherapy for stage IV NSCLC

3

2024-02-28

Signe Friesland

24/014

BEAMION-Lung2 . A Phase III, open-label, randomized, active-controlled, multi-centre trial evaluating orally administered BI 1810631 compared with standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic - non-small cell lung cancer harbouring HER2 tyrosine kinase domain mutations

3

2024-06-27

Simon Ekman

24/037

MK-2870-009_Lunga. A Randomized Phase 3 Study of MK-2870 plus Platinum vs. MK-2870 vs. Platinum Doublets in EGFR-mutated, Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors

3

2024-08-15

Simon Ekman

24/084

Galaxies Lung-301 (GSK4428859A). A Randomized, Multi-Center, Double-blind, Placebo Controlled, Phase 3 Study to Investigate Safety and Efficacy of GSK4428859A in combination with Dostarlimab compared with Placebo in combination with Pembrolizumab in Participants with Previously Untreated Locally Advanced, Unresectable or Metastatic PD-L1 Selected Non-Small Cell Lung Cancer (NSCLC)

3

2025-02-12

Hannah Björn Andtback

Huvud- och halscancer

 Nr Namn

Fas

Startdatum Ansvarig prövare

17/034

Artscan IV. A nonrandomized multicenter observational study of all reirradiation in patients with head and neck cancer with special focus on patients receiving proton therapy

Ej tillämpbar

2019-04-24

Michael Gubanski

18/025

ARTSCAN V. ARTSCAN V; Photon therapy versus proton therapy in early tonsil cancer

2

2019-08-06

Michael Gubanski

24/002

Predict-HPV-HNC. Studier på markörer för bättre prognosbedömning, uppföljning och behandling av humant papillomvirus positiv huvudhalscancer

Ej tillämpbar

2024-01-25

Mark Zupancic

24/021

JADE/219885. A randomized, double-blind, placebo-controlled phase 3 study to evaluate Dostarlimab as sequential therapy after chemoradiation in participants with locally advanced unresected Head and Neck squamous cell carcinoma

3

2024-08-15

Hanna Carstens

24/054

PRO-GLIO. PROton versus photon therapy in IDH-mutated diffuse grade 2 and 3 GLIOmas

3

2024-10-15

Mark Zupancic

Okänd primärtumör

Tyvärr är inga studier aktuella just nu.

Övriga studier, flera diagnoser

 Nr Namn

Fas

Startdatum Ansvarig prövare

23/064

HH-Prog-Markör-studien. Prognostiska markörer för bättre uppföljning av huvud-halscancer (som opereras)

Ej tillämpbar

2023-12-11

Mathias von Beckerath

Nr: Forskningsrådets nummer.
Namn: Studiens kortnamn följt av protokollets hela titel.
Fas: Kan vara Fas 1, 2, 3 eller Pilot, kombinationer av dessa, eller Ej tillämpligt.
Startdatum: Vanligen datum för startmöte eller liknande.
Ansvarig prövare: Den läkare som är ansvarig för studien inom Tema Cancer.
Ansvarig forskn.sköt: Den forskningssjuksköterska som är ansvarig.

CKC, Tema Cancer, Karolinska universitetssjukhuset 02.07.2025