Kliniska studier vid Tema Cancer

–Studier öppna för inklusion inom PO Bäckencancer–

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.

Kolorektal cancer

Nr	Namn	Fas	Startdatum	Ansvarig prövare	Ansvarig forskn.sköt	Plan. antal	Akt. inkl.
17/314	Watch and wait. Watch and wait-Icke operativ behandling vid strål- och cellgiftsbehandling.	Ej tillämpbar	2016-08-08	Anna Martling	Shahrzad Kordnejad	0	132
20/038	SOULMATE. The Swedish study of liver transplantation for non-resectable/non-ablatable colorectal liver metastases.	2	2021-04-01	Mia Karlberg	Birgitta Nässen	10	2
20/053	PRORECT. Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT):A Prospective Randomized Swedish Phase II Trial	2	2021-03-08	Alexander Valdman	Birgitta Nässén	150	55
20/073	CIM-HIPEC. The native immune system and the development of carcinomatosis among patients with colorectal cance	Ej tillämpbar	2020-01-10	Caroline Nordenvall	Madelene Ahlberg	0	161
20/074	CIM-IBD. Single-cell analysis of intestinal lymphocytes reveals targets for treatment of inflammatory bowel disease	Ej tillämpbar	2019-06-13	Caroline Nordenvall	Madelene Ahlberg	0	143
20/075	CITCCA pilot. CIrculating Tumour DNA in Colorectal CAncer, pilotstudie	Ej tillämpbar	2020-10-22	Anna Martling	Madelene Ahlberg	50	156
20/076	CRUISE. Restorative treatment with ileorectal anastomosis or ileal pouch anal anastomosis in patients with ulcerative colitis	Ej tillämpbar	2017-03-01	Caroline Nordenvall	Madelene Ahlberg	0	50
20/077	EROS. Early intervention and recovery of sexual function in men and women after treatment of rectal cancer–a randomized controlled study with tadalafil compared to standard care	2-3	2020-11-01	Christian Buchli	Hanna Rosén	70	72
21/046	EFFIPEC. EFFIPEC – Efficacy of Hyperthermic Intraperitoneal ChemotherapySingle-arm Phase I study, followed by an open-label, randomized, controlled registry-based phase III trial	1	2022-10-30	Gabriella Palmer	Birgitta Nässén	10	12
22/019	PelvEx II. Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer	3	2022-08-17	Henrik Iversen	Birgitta Nässén	0	3

Gynekologisk cancer

Nr	Namn	Fas	Startdatum	Ansvarig prövare	Ansvarig forskn.sköt	Plan. antal	Akt. inkl.
18/080	RACC. The RACC trial -Robot Assisted Approach to Cervical Cancer	3	2019-05-27	Henrik Falconer	Sara Rydén	50	149
19/044	SCAN-Mi-studien-cervix. Mikrobiomets associerade biomarkörers betydelse för utveckling och prognos av livmoderhals- och huvudhals-cancer.	Ej tillämpbar	2021-05-01	Henrik Falconer	Perihan Inekci	100	37
19/058	TITANIUM. GestaTIonal TrophoblAstic NeoplasIa assessMent	Ej tillämpbar	2022-01-01	Ulrika Joneborg	-	0	0
21/034	DOVACC. A Randomized Clinical Trial Investigating Olaparib, Durvalumab (MEDI4736) and UV1 as Maintenance Therapy in BRCAwt Patients with Recurrent Ovarian Cancer	2-3	2023-01-25	Josefin Fernebro	Sara Rydén	10	5
21/107	GeMore-studien. Genetisk och molekylär kartläggning samt riktad behandling inom gynekologisk cancer	Ej tillämpbar	2021-01-02	Josefin Fernebro	Perihan Inekci	100	228
21/108	ISGA-studien (pre-GAT01). studier av immunsystemet hos patienter med gyncancer	Ej tillämpbar	2021-10-21	Emelie Wallin	Perihan Inekci	50	103
22/069	KANDOVA. KANDOVA - A two-part Phase Ib/IIa study to evaluate the safety and tolerability of KAND567, in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID)of KAND567. An open-label, multicenter dose escalation study with an expansion cohort in women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.	1-2	2023-04-26	Hanna Dahlstrand	Sara Rydén	0	5
22/077	ct-DNA-studien på cervixcancer. Analys av cell-fritt tumör-DNA i blod.	Ej tillämpbar	2022-01-01	Kristina Hellman	Perihan Inekci	100	36
23/027	iMolE. Implementation of Molecular diagnosis of Endometrial cancer	Ej tillämpbar	2023-05-23	Emelie Wallin	Perihan Inekci	0	286
23/028	FOLERO. Frailty, quality Of Life and Early Reversal of temporary defunctioning Stoma in Ovarian Cancer	Ej tillämpbar	2024-02-29	Sahar Salehi, Daniel Hunde	Perihan Inekci/Sara Rydén	0	36
23/043	MK-2870-005/ENGOT-en23. A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice in Participants with Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy	3	2024-04-23	Magnus Frödin-Bolling	Sara Rydén	7	1
24/039	MK2870-020-Cervix. A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice as Second-line or Third-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (MK-2870-020/GOG-3101/ENGOT-Cx20)		2024-10-10	Kristina Hellman	Malin Smedman	4	0

Prostatacancer

Nr	Namn	Fas	Startdatum	Ansvarig prövare	Ansvarig forskn.sköt	Plan. antal	Akt. inkl.
14/37	SPCG-15. Primary radical prostatectomy versus primary radiotherapy for locally advanced prostate cancer: an open randomized clinical trial	3	2014-10-01	Mats Olsson	Helena Forsén	50	63
18/034	PSMA recidiv-studien. En randomiserad jämförelse mellan konventionell "Salvage" strålbehandling och individualiserad PSMA-pet styrd behandling hos patienter med biokemiskt återfall (PSA) efter prostatacancer operation	2	2018-10-30	Stefan Carlsson	Hanna Christensson	350	194
18/066	ProBio . ProBio: An outcome-adaptive and randomized multi-arm biomarker driven study in patients with metastatic castrate resistant prostate cancer mCRPC)	2	2019-05-27	Anders Ullén	Amanda Hallgren	20	35
21/023	MK3475-365. Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC)	1-2	2022-04-01	Enrique Castellanos	Katarina Hammarlund	35	2
21/048	PRIS. Prostate Cancer IRE Study (PRIS) – A randomized controlled trial comparing focal to radical treatment in localized prostate cancer	3	2022-09-07	Anna Lantz	Hanna Christensson	184	63
22/038	METRO. Metastasis directed Stereotactic Body Radiotherapy (SBRT) for Oligo metastatic Hormone sensitive Prostate Cancer	3	2023-10-19	Mattias Hedman	Helena Forsén	10	10
23/068	CAAA617A12402. Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of lutetium (177Lu) vipivotide tetraxetan in Adult Participants with Prostate Cancer	4	2024-01-30	Enrique Castellanos	Johanna Löfberg Betts	3	0
23/069	OMAHA-003. A Phase 3 Randomized, Open-label Study of MK-5684 versus Alternative Abiraterone Acetate or Enzalutamide in Participants with metastatic Castration Resistant Prostate Cancer (mCRPC) Previously Treated with Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy	3	2024-05-10	Enrique Castellanos	Hanna Christensson	7	2
23/072	OMAHA-004. A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment with One Nextgeneration Hormonal Agent (NHA)	3	2024-06-01	Anna Kristiansen	Jenny Johansson	5	1

Blåscancer

Nr	Namn	Fas	Startdatum	Ansvarig prövare	Ansvarig forskn.sköt	Plan. antal	Akt. inkl.
21/041	BioBladder. Biomarker profiling to predict response and survival in patients receiving systemic therapy for advanced urothelial cancer	Ej tillämpbar	2022-03-10	Anders Ullén	Katrin Fines	60	144
21/067	RWD Avelumab. A Swedish nationwide real-world data study of maintenanceavelumab in patients with advanced urothelial cancer withoutprogression following first-line platinum-based chemotherapy	4	2022-08-15	Faith Jawdat	Katrin Fines	0	42
23/057	V940-005-00-Blåsa. A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with High-Risk Muscle-Invasive Urothelial Carcinoma Post-Radical Resection	2	2024-06-01	Anders Ullen	Helena Forsén	4	0

Njur- och testikelcancer

Nr	Namn	Fas	Startdatum	Ansvarig prövare	Ansvarig forskn.sköt	Plan. antal	Akt. inkl.
18/016	MIR-Studien . MikroRNA som markörer för monitorering av sjukdomsaktivitet, utvärdering av effekt av cytostatikabehandling, samt verktyg för tidig upptäckt av recidiv av metastatisk testikelcancer. Implentering av MIR-Studien	Ej tillämpbar	2019-04-23	Anders Kjellman	Josephine Johansson/Katrin Fines	250	291
19/002	TINCA II - njurcancer. Det immunologiska landskapet i njurcancer	Ej tillämpbar	2021-09-01	Ulrika Harmenberg	Katrin Fines	100	38

Urologiska sjukdomar

Tyvärr är inga studier aktuella just nu.

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