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	Ansvarig forskn.sköt	Plan. antal	Akt. inkl.
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	Amanda Hallgren	50	271
17/414	Studie immunologisk aktivitet hos melanomtumörer. Studier av immunologisk aktivitet hos melanomtumörer som opereras bort	Ej tillämpbar	2021-10-18	Hildur Helgadottir	Katrin Fines	50	7
20/036	PROMMEL. Precision Radiation of Immune Checkpoint Therapy Resistant Melanoma Metastases	2	2021-03-08	Hildur Helgadottir	Katarina Hammarlund	16	12
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	Katrin Fines	100	20
22/060	RELA-127. A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixeddose Combination versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants with Previously Untreated Metastatic or Unresectable Melanoma	3	2023-10-05	Hildur Helgadottir	Amanda Hallgren	10	2
22/076	Melbank-studien. Studier på primära melanom och högrisk sjukdom.	Ej tillämpbar	2023-06-19	Hanna Eriksson	Katrin Fines	100	2
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	Katarina Hammarlund	0	0

Lungcancer

Nr	Namn	Fas	Startdatum	Ansvarig prövare	Ansvarig forskn.sköt	Plan. antal	Akt. inkl.
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	Sofia Friberg	100	93
19/089	PreDDLung-studien tid Biobank-Lung. Uppbyggnad av biobank för lungcancerforskning vid Karolinska Universitetssjukhuset	Ej tillämpbar	2021-05-10	Simon Ekman	Therese Mattsson	200	592
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	Leia Ollmar	2	4
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	Eeva Alamartimo	20	1
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	Sara Severin	2	2
22/004	PROTHYM. Phase II non-randomized study on Proton Radiotherapy Of Thymic Malignancies	2	2022-04-19	Karin Lindberg	Sara Severin	15	8
22/006	LUCA-S. Web-based symptom monitoring and survival in advanced stage lung cancer	3	2022-12-01	Gunnar Wagenius	Helena Ullgren	0	33
22/026	BO42777 HORIZON01. A phase 1-3, multicenter study evaluating the efficacy and safety of multiple therapies in cohorts of patients selected according tobiomarker status, with locally advanced, unresectable, stage IIInon-small cell lung cancer	3	2023-12-20	Georgios Tsakonas	Leia Ollmar	2	1
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	Sara Severin	15	17
22/054	AVANZAR-Dato-DXd i NSCLC. A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations	3	2023-03-01	Luigi De Petris	Julia Sjökvist	5	3
22/056	KSAB. Sotorasib followed by SBRT to 1-3 lesions in advanced NSCLC with KRASG12C mutation	1	2023-06-20	Karin Lindberg	Eeva Alamartimo	20	3
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	Sara Severin	10	0
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-generationEGFR-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	Julia Sjökvist	0	19
23/046	Bridge D9106C00002. A multicentre, Phase II, single-arm, interventional study ofneoadjuvant durvalumab and platinum-based chemotherapy (CT), followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab, inparticipants with resectable or borderline resectable stage IIB-IIIB Non-small Cell Lung Cancer (NSCLC)	2	2024-08-15	Karin Lindberg	Eeva Alamartimon	0	0
23/078	MARS. Multicentre phase III study: Addition of Radiotherapy to Standard chemotherapy for stage IV NSCLC	3	2024-02-28	Signe Friesland	Leia Ollmar	1030	6
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	Julia Sjökvist	12	0
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	Sara Severin	5	0
24/054	PRO-GLIO. PROton versus photon therapy in IDH-mutated diffuse grade 2 and 3 GLIOmas	3	2024-10-15	Mark Zupancic	Julia Sjökvist	25	0

Huvud- och halscancer

Nr	Namn	Fas	Startdatum	Ansvarig prövare	Ansvarig forskn.sköt	Plan. antal	Akt. inkl.
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	Sara Severin	10	26
18/025	ARTSCAN V. ARTSCAN V; Photon therapy versus proton therapy in early tonsil cancer	2	2019-08-06	Michael Gubanski	Sara Severin	20	14
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	Anna Borgström	0	47
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	Julia Sjökvist	0	0

Okänd primärtumör

Tyvärr är inga studier aktuella just nu.

Övriga studier, flera diagnoser

Nr	Namn	Fas	Startdatum	Ansvarig prövare	Ansvarig forskn.sköt	Plan. antal	Akt. inkl.
21/085	CanPAM. Patienters erfarenhet av delaktighet i cancervården	Ej tillämpbar	2022-02-14	Helena Ullgren	Helena Ullgren	80	31
23/064	Pred-HH-Markstudien. Prognostiska markörer för bättre uppföljning av huvud-halscancer (som opereras)	Ej tillämpbar	2023-12-11	Mathias von Beckerath	Anna Borgström	20	5

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 05.02.2025