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

17/314

Watch and wait. Watch and wait-Icke operativ behandling vid strål- och cellgiftsbehandling.

Ej tillämpbar

2016-08-08

Anna Martling

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

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

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

20/075

CITCCA pilot. CIrculating Tumour DNA in Colorectal CAncer, pilotstudie

Ej tillämpbar

2020-10-22

Anna Martling

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

21/046

EFFIPEC. EFFIPEC – Efficacy of Hyperthermic Intraperitoneal Chemotherapy Single-arm Phase I study, followed by an open-label, randomized, controlled registry-based phase III trial

1

2022-10-30

Gabriella Palmer

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

24/082

HILOS. HIPEC and LOng of Stay - Patienters upplevelse och erfarenheter av högspecialiserad buk- och bäckencancerkirurgi

Ej tillämpbar

2024-11-22

Tina Gustavell

24/088

SELSA. Selective defunstionen stoma approach in low anterior resection for rectal cancer(SELSA): a prospective study and a nested randomised clinical trial

Ej tillämpbar

2024-10-31

Naseer Baloch

Gynekologisk cancer

 Nr Namn

Fas

Startdatum Ansvarig prövare

18/080

RACC. The RACC trial -Robot Assisted Approach to Cervical Cancer

3

2019-05-27

Henrik Falconer

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

19/058

TITANIUM. GestaTIonal TrophoblAstic NeoplasIa assessMent

Ej tillämpbar

2022-01-01

Ulrika Joneborg

21/107

GeMore-studien. Genetisk och molekylär kartläggning samt riktad behandling inom gynekologisk cancer

Ej tillämpbar

2021-01-02

Josefin Fernebro

21/108

ISGA-studien (pre-GAT01). studier av immunsystemet hos patienter med gyncancer

Ej tillämpbar

2021-10-21

Emelie Wallin

22/077

ct-DNA-studien på cervixcancer. Analys av cell-fritt tumör-DNA i blod.

Ej tillämpbar

2022-01-01

Kristina Hellman

23/004

PARP-PET. [11C]AZ14193391 - PET as a selection tool for treatment with PARP inhibitors in patients with metastatic solid tumors

Ej tillämpbar

2025-01-30

Rimma Axelsson/ onk: Josefin Fernebro

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

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

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)

3

2024-10-30

Kristina Hellman

Prostatacancer

 Nr Namn

Fas

Startdatum Ansvarig prövare

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

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

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

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

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

22/038

METRO. Metastasis directed Stereotactic Body Radiotherapy (SBRT) for Oligo metastatic Hormone sensitive Prostate Cancer

3

2023-10-19

Mattias Hedman

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

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

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

24/016

IPA. Incontinence Post robot assisted radical prostatectomy, Anatomical and functional causes

Ej tillämpbar

2024-11-14

Stefan Carlsson

Blåscancer

 Nr Namn

Fas

Startdatum Ansvarig prövare

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

21/067

RWD Avelumab. A Swedish nationwide real-world data study of maintenance avelumab in patients with advanced urothelial cancer without progression following first-line platinum-based chemotherapy

4

2022-08-15

Faith Jawdat

23/056

SGNDV-001/KN-D74. An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2

3

2024-12-10

Anders Ullén

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

Njur- och testikelcancer

 Nr Namn

Fas

Startdatum Ansvarig prövare

19/002

TINCA II - njurcancer. Det immunologiska landskapet i njurcancer

Ej tillämpbar

2021-09-01

Ulrika Harmenberg

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 11.05.2025