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Ovarian CancerPhase 2NCT06815497

Telmisartan in Combination With Cytotoxic Regimens in Platinum-Resistant Ovarian Cancer

A Phase 2 study testing Telmisartan in people with Ovarian Cancer, run by Tyler J Curiel at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The primary study objective is to assess progression-free survival in patients with ovarian cancer receiving telmisartan plus selected standard of care chemotherapy regimens versus historical controls. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Telmisartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesUnited States
Study dates
21 Jan 2026to 14 May 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Able and willing to provide informed consent.
  • Histologically proven high-grade serous ovarian carcinomas (HGSOC)
  • Platinum-resistant or refractory ovarian cancer (OC) defined as progression of disease on carboplatin or growth of disease as detected on computed tomography (CT) scan within 6 months of last platinum treatment
  • To receive the allowable standard of care (SOC) chemotherapy regimens for OC
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  • Life expectancy ≥2 months
  • Adequate organ and bone marrow reserve function as indicated by the following:
  • Adequate hematological function, defined as absolute neutrophil count (ANC) ≥1.5 x 10^9/L, platelet count ≥100 x 10^9/L, and hemoglobin ≥8 g/dL without recent transfusion (defined as a transfusion that has occurred within 2 weeks of the hemoglobin measurement)
  • Adequate liver function, defined as total bilirubin level ≥1.5 x institutional upper limit of normal (IULN), aspartate aminotransferase (AST) ≤ 2.5 x IULN, and alanine aminotransferase (ALT) ≤ 2.5 x IULN
  • Adequate renal function defined as creatinine ≤ 1.5 x IULN or measured or calculated creatinine clearance ≥ 40 mL/min per institutional standard. Assessment methods must be recorded.
  • Adequate coagulation, defined as international normalized ratio (INR) or prothrombin time ≤ 1.5 x IULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x IULN (unless patient receiving anticoagulant therapy).
  • Female patients of childbearing potential (FCBP) must agree to use highly effective contraceptive method(s) while on this study and for at least 3 months after the last dose of chemotherapy
  • FCBP must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication). Non-childbearing potential is defined as 1 of the following:
  • ≥ 45 years of age and has not had menses for >1 year
  • Amenorrheic for > 2 years without a hysterectomy and/or oophorectomy and follicle stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation
  • Status is post-hysterectomy, -oophorectomy, or -tubal ligation
  • Genetic defect precluding pregnancy
  • No contraindication to telmisartan*, including angiotensin converting enzyme (ACE) inhibitor use in the 6 weeks prior to telmisartan start on trial
  • Systolic blood pressure maintained at ≥ 110 mm Hg during study enrollment assessment and throughout the study.

Who cannot join

  • Patients who meet any of the criteria below may NOT be eligible to participate in this study:
  • Patients who are unable to provide informed consent.
  • Patients with known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they must have an undetectable HCV viral load
  • Hypertensive urgency or emergency as defined
  • Incarcerated or homeless
  • Pregnant or lactating.
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  • Individuals who are not yet adults <18 years of age.
  • On lithium therapy in any form
  • Received rituximab or amifostine within 30 days prior to first telmisartan dose on this study
  • Active, serious infection requiring treatment
  • Clinically significant (i.e., active) cardiovascular disease, cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥II), or serious uncontrolled cardiac arrhythmia requiring medication
  • History or current evidence of any condition, therapy, and active infections, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
  • Taking ramapril
  • Using bevacizumab as part of their SOC chemotherapy regimen
  • If known to be HIV-infected, have undetectable HIV viral load by any accepted standard of care HIV detection method

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kayla Fay contact

603-650-5000

AskClinicalTrials@hitchcock.org

United States2 sites, 2 recruiting

  • Dartmouth Hitchcock

    Lebanon, New Hampshire, 03756

    Ivy Wilkinson-Ryan, MD

    Ivy Wilkinson-Ryan, MD

    Recruiting

  • Dartmouth-Hitchcock Manchester

    Manchester, New Hampshire, 03104

    Ivy Wilkinson-Ryan, MD, 603-650-5000, ivy.wilkinson-ryan@hitchcock.org

    Ivy Wilkinson-Ryan, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase II Non-Randomized, Unblinded, Single-Center Trial of Telmisartan in Combination With Cytotoxic Regimens in Platinum-Resistant Ovarian Cancer Versus Historical Best Supportive Care

The primary study objective is to assess progression-free survival in patients with ovarian cancer receiving telmisartan plus selected standard of care chemotherapy regimens versus historical controls.

Read the detailed description

This is an open label, single-arm Phase II trial of telmisartan plus selected standard of care chemotherapy regimens containing an anthracycline or taxane. The primary study objective is to assess progression-free survival.

Conditions
Ovarian Cancer
Being tested
Telmisartan
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelmisartanDrug

    Also called Micardis

    Telmisartan will be introduced as a 40 mg tablet to be taken orally once daily. In participants not experiencing telmisartan dose limiting toxicity, the dose will be escalated to a maximum of 80 mg

Study groups in NCT06815497
Study groupRoleWhat they receive
Telmisartan with Standard of Care TreatmentExperimentaloral telmisartan in combination with standard of care chemotherapy. chemotherapy regimen is preferably doxorubicin (preferably liposomal doxorubicin) but paclitaxel, nab-paclitaxel, or docetaxel are allowed per investigator or patient preference
Receives: Drug: Telmisartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Progression free survival is defined as the time between the initiation of telmisartan to progression, as defined by RECIST criteria, on a computed tomography scan.

    Measured: 48 months

Secondary outcomes (2)

  1. Treatment tolerability

    Treatment tolerability will be quantified as the proportion of patients with a toxicity related to telmisartan and the proportion of patients who stopped telmisartan due to its toxicity

    Measured: 24 months

  2. Circulating tumor DNA changes

    Peripheral blood will be drawn throughout the study and tested for circulating tumor DNA (ctDNA) damage. The goal is to understand tumor genetic changes in response to adding telmisartan to test if changes predictive of treatment response or failure can be detected.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2025
  2. Study start21 Jan 2026
  3. Primary completion14 Apr 2027 (estimated)
  4. Study completion14 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06815497
Sponsor's protocol ID
STUDY02002599
Other IDs
24WIL599
Status last verified
Jan 2026
First submitted
3 Feb 2025
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Richardson DL, Eskander RN, O'Malley DM. Advances in Ovarian Cancer Care and Unmet Treatment Needs for Patients With Platinum Resistance: A Narrative Review. JAMA Oncol. 2023 Jun 1;9(6):851-859. doi: 10.1001/jamaoncol.2023.0197.

    PubMed 37079311

  • Moore KN, Angelergues A, Konecny GE, Garcia Y, Banerjee S, Lorusso D, Lee JY, Moroney JW, Colombo N, Roszak A, Tromp J, Myers T, Lee JW, Beiner M, Cosgrove CM, Cibula D, Martin LP, Sabatier R, Buscema J, Estevez-Garcia P, Coffman L, Nicum S, Duska LR, Pignata S, Galvez F, Wang Y, Method M, Berkenblit A, Bello Roufai D, Van Gorp T; Gynecologic Oncology Group Partners and the European Network of Gynaecological Oncological Trial Groups. Mirvetuximab Soravtansine in FRalpha-Positive, Platinum-Resistant Ovarian Cancer. N Engl J Med. 2023 Dec 7;389(23):2162-2174. doi: 10.1056/NEJMoa2309169.

    PubMed 38055253

  • Mellman I, Chen DS, Powles T, Turley SJ. The cancer-immunity cycle: Indication, genotype, and immunotype. Immunity. 2023 Oct 10;56(10):2188-2205. doi: 10.1016/j.immuni.2023.09.011.

    PubMed 37820582

  • Drerup JM, Liu Y, Padron AS, Murthy K, Hurez V, Zhang B, Curiel TJ. Immunotherapy for ovarian cancer. Curr Treat Options Oncol. 2015 Jan;16(1):317. doi: 10.1007/s11864-014-0317-1.

    PubMed 25648541

  • Palaia I, Tomao F, Sassu CM, Musacchio L, Benedetti Panici P. Immunotherapy For Ovarian Cancer: Recent Advances And Combination Therapeutic Approaches. Onco Targets Ther. 2020 Jun 26;13:6109-6129. doi: 10.2147/OTT.S205950. eCollection 2020.

    PubMed 32617007

  • Muaibati M, Abuduyilimu A, Zhang T, Dai Y, Li R, Huang F, Li K, Tong Q, Huang X, Zhuang L. Efficacy of immune checkpoint inhibitor monotherapy or combined with other small molecule-targeted agents in ovarian cancer. Expert Rev Mol Med. 2023 Jan 24;25:e6. doi: 10.1017/erm.2023.3.

    PubMed 36691778

  • Alexandrov LB, Nik-Zainal S, Wedge DC, Aparicio SA, Behjati S, Biankin AV, Bignell GR, Bolli N, Borg A, Borresen-Dale AL, Boyault S, Burkhardt B, Butler AP, Caldas C, Davies HR, Desmedt C, Eils R, Eyfjord JE, Foekens JA, Greaves M, Hosoda F, Hutter B, Ilicic T, Imbeaud S, Imielinski M, Jager N, Jones DT, Jones D, Knappskog S, Kool M, Lakhani SR, Lopez-Otin C, Martin S, Munshi NC, Nakamura H, Northcott PA, Pajic M, Papaemmanuil E, Paradiso A, Pearson JV, Puente XS, Raine K, Ramakrishna M, Richardson AL, Richter J, Rosenstiel P, Schlesner M, Schumacher TN, Span PN, Teague JW, Totoki Y, Tutt AN, Valdes-Mas R, van Buuren MM, van 't Veer L, Vincent-Salomon A, Waddell N, Yates LR; Australian Pancreatic Cancer Genome Initiative; ICGC Breast Cancer Consortium; ICGC MMML-Seq Consortium; ICGC PedBrain; Zucman-Rossi J, Futreal PA, McDermott U, Lichter P, Meyerson M, Grimmond SM, Siebert R, Campo E, Shibata T, Pfister SM, Campbell PJ, Stratton MR. Signatures of mutational processes in human cancer. Nature. 2013 Aug 22;500(7463):415-21. doi: 10.1038/nature12477. Epub 2013 Aug 14.

    PubMed 23945592

  • Zhang L, Conejo-Garcia JR, Katsaros D, Gimotty PA, Massobrio M, Regnani G, Makrigiannakis A, Gray H, Schlienger K, Liebman MN, Rubin SC, Coukos G. Intratumoral T cells, recurrence, and survival in epithelial ovarian cancer. N Engl J Med. 2003 Jan 16;348(3):203-13. doi: 10.1056/NEJMoa020177.

    PubMed 12529460

  • Curiel TJ, Coukos G, Zou L, Alvarez X, Cheng P, Mottram P, Evdemon-Hogan M, Conejo-Garcia JR, Zhang L, Burow M, Zhu Y, Wei S, Kryczek I, Daniel B, Gordon A, Myers L, Lackner A, Disis ML, Knutson KL, Chen L, Zou W. Specific recruitment of regulatory T cells in ovarian carcinoma fosters immune privilege and predicts reduced survival. Nat Med. 2004 Sep;10(9):942-9. doi: 10.1038/nm1093. Epub 2004 Aug 22.

    PubMed 15322536

  • Mariniello M, Petruzzelli R, Wanderlingh LG, La Montagna R, Carissimo A, Pane F, Amoresano A, Ilyechova EY, Galagudza MM, Catalano F, Crispino R, Puchkova LV, Medina DL, Polishchuk RS. Synthetic Lethality Screening Identifies FDA-Approved Drugs that Overcome ATP7B-Mediated Tolerance of Tumor Cells to Cisplatin. Cancers (Basel). 2020 Mar 6;12(3):608. doi: 10.3390/cancers12030608.

    PubMed 32155756

  • Fujita N, Fujita K, Iwama H, Kobara H, Fujihara S, Chiyo T, Namima D, Yamana H, Kono T, Takuma K, Hirata M, Kobayashi K, Kato K, Kamada H, Morishita A, Tsutsui K, Himoto T, Okano K, Suzuki Y, Masaki T. Antihypertensive drug telmisartan suppresses the proliferation of gastric cancer cells in vitro and in vivo. Oncol Rep. 2020 Jul;44(1):339-348. doi: 10.3892/or.2020.7607. Epub 2020 May 7.

    PubMed 32627043

  • Samukawa E, Fujihara S, Oura K, Iwama H, Yamana Y, Tadokoro T, Chiyo T, Kobayashi K, Morishita A, Nakahara M, Kobara H, Mori H, Okano K, Suzuki Y, Himoto T, Masaki T. Angiotensin receptor blocker telmisartan inhibits cell proliferation and tumor growth of cholangiocarcinoma through cell cycle arrest. Int J Oncol. 2017 Dec;51(6):1674-1684. doi: 10.3892/ijo.2017.4177. Epub 2017 Oct 23.

    PubMed 29075786

  • Oura K, Tadokoro T, Fujihara S, Morishita A, Chiyo T, Samukawa E, Yamana Y, Fujita K, Sakamoto T, Nomura T, Yoneyama H, Kobara H, Mori H, Iwama H, Okano K, Suzuki Y, Masaki T. Telmisartan inhibits hepatocellular carcinoma cell proliferation in vitro by inducing cell cycle arrest. Oncol Rep. 2017 Nov;38(5):2825-2835. doi: 10.3892/or.2017.5977. Epub 2017 Sep 20.

    PubMed 29048654

  • Fujihara S, Morishita A, Ogawa K, Tadokoro T, Chiyo T, Kato K, Kobara H, Mori H, Iwama H, Masaki T. The angiotensin II type 1 receptor antagonist telmisartan inhibits cell proliferation and tumor growth of esophageal adenocarcinoma via the AMPKalpha/mTOR pathway in vitro and in vivo. Oncotarget. 2017 Jan 31;8(5):8536-8549. doi: 10.18632/oncotarget.14345.

    PubMed 28052030

  • Pu Z, Zhu M, Kong F. Telmisartan prevents proliferation and promotes apoptosis of human ovarian cancer cells through upregulating PPARgamma and downregulating MMP-9 expression. Mol Med Rep. 2016 Jan;13(1):555-9. doi: 10.3892/mmr.2015.4512. Epub 2015 Nov 6.

    PubMed 26548340

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telmisartan in people with Ovarian Cancer, run by Tyler J Curiel at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kayla Fay (603-650-5000, AskClinicalTrials@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06815497, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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