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Cervical CancerPhase 2PRIMMONCT03192059

Study of Pembrolizumab, Radiation and Immune Modulatory Cocktail in Cervical/Uterine Cancer

A Phase 2 study testing Pembrolizumab, Radiation and Vitamin D in people with Cervical Cancer and Endometrial Cancer, run by University Hospital, Ghent at 4 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase II study in patients with advanced and/refractory cervical cancer, endometrial carcinoma or uterine sarcoma. Patients will be treated with an immunomodulatory cocktail (Vitamin D, aspirin, Cyclophosphamide and Lansoprazole), followed by pembrolizumab, combined with radiation. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pembrolizumab, Radiation and Vitamin D
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
4 sitesBelgium
Study dates
1 Jul 2017to 30 Jun 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Have histologically confirmed endometrial carcinoma, cervical carcinoma or uterine sarcoma, refractory or persistent to chemotherapy or recurrent disease after at least one line of chemotherapy.
  • Presence of an index lesion amenable to hypofractionated stereotactic radiotherapy
  • At least one lesion outside the radiation field that can be followed by imaging for clinical response according to RECIST and irRC
  • Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion before and after radiotherapy if technically feasible.
  • Have a performance status of 0 or 1 or 2 on the ECOG Performance Scale.
  • Demonstrate adequate organ function

Who cannot join

  • Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agent
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to the first dose of trial treatment,
  • Known history of active TB (Bacillus Tuberculosis), Human Immunodeficiency Virus (HIV), HTLV or syphilis,non-infectious pneumonitis, has active autoimmune disease.
  • Has active central nervous system metastases and/or carcinomatous meningitis

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

  • University Hospital Antwerp

    Antwerp

  • Institut Jules Bordet

    Brussels, 1000

  • University Hospital Gent

    Ghent, 9000

  • CMSE Namur

    Namur

Other trials in Belgium

About this study

Official title: A Phase II Investigation of Pembrolizumab (Keytruda) in Combination With Radiation and an Immune Modulatory Cocktail in Patients With Cervical and Uterine Cancer (PRIMMO Trial)

This is a Phase II study in patients with advanced and/refractory cervical cancer, endometrial carcinoma or uterine sarcoma.

Patients will be treated with an immunomodulatory cocktail (Vitamin D, aspirin, Cyclophosphamide and Lansoprazole), followed by pembrolizumab, combined with radiation. In addition, patients will take Curcumin, a food supplement.

Read the detailed description

This is a Phase II multi-center, open-label, non-randomized, 3-cohort study in patients with advanced and/or refractory cervical cancer, endometrial carcinoma or uterine sarcoma. Patients will be treated by an immunomodulatory cocktail (consisting of a daily intake of 2000 IU Vitamin D, 325 mg aspirin, 50 mg Cyclophosphamide and 180 or 30 mg Lansoprazole alternating weekly), followed by pembrolizumab administered intravenously at 200 mg in 21-day treatment cycles, combined with radiation (3x 8Gy in 48h-intervals). In addition, patients will take Curcumin, a food supplement on a daily basis.

Being tested
Pembrolizumab, Radiation, Vitamin D, Aspirin, Lansoprazole
Keywords
Immunotherapy, Radiotherapy, Immune-modulatory cocktail
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms, Uterine Neoplasms

What participants receive

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

  • PembrolizumabDrug

    Efficacy of the combined treatment

  • RadiationRadiation

    Efficacy of the combined treatment

  • Vitamin DDrug

    Efficacy of the combined treatment

  • AspirinDrug

    Efficacy of the combined treatment

  • LansoprazoleDrug

    Efficacy of the combined treatment

  • CyclophosphamideDrug

    Efficacy of the combined treatment

  • CurcuminDietary supplement

    Efficacy of the combined treatment

Study groups in NCT03192059
Study groupRoleWhat they receive
experimental armExperimentalPembrolizumab, immune modulatory cocktail composed of Vitamin D, Lansoprazole Teva, Cyclophosphamide and Aspirine, radiation and Curcumin
Receives: Drug: Pembrolizumab; Radiation: Radiation; Drug: Vitamin D; Drug: Aspirin; Drug: Lansoprazole; Drug: Cyclophosphamide; Dietary Supplement: Curcumin

What is being measured

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

  1. Objective response rate at week 26

    Efficacy (objective response rate) at week 26 according to immune related response criteria (irRC)

    Measured: week 26

Secondary outcomes (8)

  1. Incidence of treatment-emergent adverse events (Safety according to CTCAE4.0).

    The number of unmanageable dose limiting toxicities will be reported for the run-in period and the main trial. This analysis will be performed for both the Full Analysis Set (FAS; evaluable patiënts) and extended FAS (eFAS; all patients included in the trial).

    Measured: up to 30 days post end of study treatment

  2. Objective response rate

    Objective response rate at week 26 according to RECIST criteria

    Measured: week 26

  3. Best OR

    Best overall response

    Measured: week 26

  4. PFS

    At weeks 26, 52, 75, 104, 130 and 156 the proportion of progression-free patients will be estimated with a 95% confidence interval.

    Measured: up to 156 weeks

  5. Median PFS

    At weeks 26, 52, 75, 104, 130 and 156 the median PFS will be calculated.

    Measured: up to 156 weeks

  6. OS

    At weeks 26, 52, 75, 104, 130 and 156 the proportion of patients surviving will be estimated with a 95% confidence interval.

    Measured: up to 156 weeks

  7. Median OS

    At weeks 26, 52, 75, 104, 130 and 156 the median survival will be calculated.

    Measured: up to 156 weeks

  8. Quality of life assessment

    Quality of life as measured by FACT-Cx questionnaire for the cervical cancer group and by the FACT-G questionnaire for the endometrial carcinoma and uterine sarcoma group. Descriptive statistics of the total score at each visit and the difference with the baseline visit for all other visits will be reported.

    Measured: Quality of life questionnaires will be completed by the patients at baseline, after 3 months of therapy, after 6 months of treatment (end of treatment) and finally 3 months after therapy.

Timeline

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

  1. First posted19 Jun 2017
  2. Study start1 Jul 2017
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

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
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03192059
Sponsor's protocol ID
2016-001569-97
Other IDs
2016
Acronym
PRIMMO
Status last verified
May 2018
First submitted
29 May 2017
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baiden-Amissah REM, Tuyaerts S, Annibali D, Herreros-Pomares A, De Wispelaere W, Benedetto RM, De Jaeghere EA, Van Nuffel AMT, Vuylsteke P, Henry S, Bich Trinh X, Van Dam PA, Aspeslagh S, De Caluwe A, Naert E, Vandecasteele K, Denys HG, Amant F. Circulating immune cell profiling in advanced cervical and endometrial cancer patients treated with PD-1 blockade, radiotherapy, and immune modulation in the PRIMMO trial. Front Immunol. 2026 May 21;17:1794131. doi: 10.3389/fimmu.2026.1794131. eCollection 2026.

    PubMed 42253973

  • De Jaeghere EA, Hamerlinck H, Tuyaerts S, Lippens L, Van Nuffel AMT, Baiden-Amissah R, Vuylsteke P, Henry S, Trinh XB, van Dam PA, Aspeslagh S, De Caluwe A, Naert E, Lambrechts D, Hendrix A, De Wever O, Van de Vijver KK, Amant F, Vandecasteele K, Verhasselt B, Denys HG. Associations of the gut microbiome with outcomes in cervical and endometrial cancer patients treated with pembrolizumab: Insights from the phase II PRIMMO trial. Gynecol Oncol. 2024 Dec;191:275-286. doi: 10.1016/j.ygyno.2024.10.020. Epub 2024 Nov 7.

    PubMed 39515198

  • De Jaeghere EA, Tuyaerts S, Van Nuffel AMT, Belmans A, Bogaerts K, Baiden-Amissah R, Lippens L, Vuylsteke P, Henry S, Trinh XB, van Dam PA, Aspeslagh S, De Caluwe A, Naert E, Lambrechts D, Hendrix A, De Wever O, Van de Vijver KK, Amant F, Vandecasteele K, Denys HG. Pembrolizumab, radiotherapy, and an immunomodulatory five-drug cocktail in pretreated patients with persistent, recurrent, or metastatic cervical or endometrial carcinoma: Results of the phase II PRIMMO study. Cancer Immunol Immunother. 2023 Feb;72(2):475-491. doi: 10.1007/s00262-022-03253-x. Epub 2022 Aug 12.

    PubMed 35960332

  • Tuyaerts S, Van Nuffel AMT, Naert E, Van Dam PA, Vuylsteke P, De Caluwe A, Aspeslagh S, Dirix P, Lippens L, De Jaeghere E, Amant F, Vandecasteele K, Denys H. PRIMMO study protocol: a phase II study combining PD-1 blockade, radiation and immunomodulation to tackle cervical and uterine cancer. BMC Cancer. 2019 May 28;19(1):506. doi: 10.1186/s12885-019-5676-3.

    PubMed 31138229

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Radiation and Vitamin D in people with Cervical Cancer and Endometrial Cancer, run by University Hospital, Ghent at 4 sites in Belgium.

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 6 inclusion and 5 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: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate at week 26 (time frame: week 26). 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 NCT03192059, which also lists 4 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 8 Sep 2021.

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