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Kaposi SarcomaPhase 2KAPKEYNCT03469804

Phase II Multicentric Study of Pembrolizumab in Classic or Endemic Kaposi's Sarcoma

A Phase 2 study testing Pembrolizumab in people with Kaposi Sarcoma and Progression, Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Classic and endemic Kaposi's sarcoma (KS) are lymphangio-proliferations associated with human herpes virus 8 (HHV8), which treatment is poorly codified. Chemotherapies give at best 30-60% of transient responses. While interferon responses are frequent, this drug is often poorly tolerated in elderly patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kaposi Sarcoma, Progression, Disease
What is being tested?
Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteFrance
Study dates
1 Jul 2018to 20 Sep 2020
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Classic or endemic histologically confirmed KS
  • Progressive disease
  • KS with more than 10 lesions or involving more than one limb segment or with involvement >3% body surface
  • KS with at least 4 lesions ≥5mm
  • KS with at least 1 other cutaneous tumor available for repeated pharmacodynamics evaluation and be willing to provide tissue from cutaneous biopsy of a tumor lesion
  • At least 4 weeks washout for all KS specific therapies including chemotherapy and immunotherapy
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  • Provide written, informed consent prior to the performance of any study specific procedures
  • Be ≥ 18 years of age on day of signing informed consent.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • Demonstrate adequate organ function:
  • Hematological : Absolute neutrophil count (ANC) ≥1,000/mm3, Platelets ≥100,000 / mm3, Hemoglobin ≥ 9 g/dL Renal: Calculated creatinine clearance ≥40 mL/min (using Modification of diet in renal disease (MDRD) formula) Hepatic: AST (SGOT) and ALT (SGPT) ≤ 2.5xULN, serum total bilirubin ≤ 1.5xULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels >1.5xULN.
  • Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication
  • Have a health insurance

Who cannot join

  • Has a known history of organ transplantation or HIV (HIV 1/2 antibodies detected at selection) Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has KS with symptomatic visceral involvement unless no other therapeutic option is available Previously received treatments with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibody or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
  • Has a known history of active infectious hepatitis, type B (HBsAg detected) or C (HCV RNA detected) or active TB (Tuberculosis Bacillus).
  • Has an active infection requiring systemic therapy.
  • Has hypersensitivity to pembrolizumab or any of its excipients.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within last 4 weeks or who has not recovered (i.e., > Grade 1 at selection) from adverse events due to agents administered more than 4 weeks earlier.
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  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 3 weeks prior to study Day 1 or who has not recovered (i.e., > Grade 1 at selection) from adverse events due to a previously administered agent (Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study). (Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy).
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with vitiligo, type I diabetes mellitus, hypothyroidism, psoriasis non requiring systemic treatment are permitted to enroll.
  • Has active non-infectious pneumonitis or known history of non-infectious pneumonitis that required steroids, severe pulmonary disease or hypoxia
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, or not willing to use adequate contraceptive methods from study Visit 1 throughout the study period up to 120 days after the last dose of study therapy.
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment or while participating in the trial.
  • Is currently participating or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Patient under guardianship or curators

Trial locations and contacts

1 site in 1 country.

Celeste LEBBE, MD PhD contact

142499590 ext. +33

celeste.lebbe@aphp.fr

Matthieu RESCHE-RIGON, MD PhD contact

142499742 ext. +33

matthieu.resche-rigon@univ-paris-diderot.fr

France1 site, 1 recruiting

  • Saint-Louis Hospital

    Paris, 75010

    Celeste Lebbe, MD PhD, 142499590 ext. +33, celeste.lebbe@aphp.fr

    laetitia Da Meda, 142499392 ext. +33, laetitia.da-meda@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: Essai de Phase II Multicentrique évaluant le Pembrolizumab Dans le Traitement de la Maladie de Kaposi Classique ou endémique

Classic and endemic Kaposi's sarcoma (KS) are lymphangio-proliferations associated with human herpes virus 8 (HHV8), which treatment is poorly codified. Chemotherapies give at best 30-60% of transient responses. While interferon responses are frequent, this drug is often poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS represents an ideal model for evaluating new drugs since patients do not receive concomitant immunosuppressive regimens nor antiviral therapies.

Pembrolizumab, an anti-PD1 monoclonal antibody has recently been shown to improve survival in several solid tumors. In KS few data are available on the role of PD1-PD-L1 axis. A significant PD-L1 expression on HHV8-associated pleural effusion lymphomas and on KS samples have been recently reported. Our experience in classical and endemic KS supports the role of this pathway with expression of PD-L1 by subpopulations of T cells but also NK cells in peripheral blood cells from these patients and expression of PD-L1 by tumor cells in KS lesions.

In this study we will evaluate the benefit and safety profile of pembrolizumab in classic and endemic KS.

Being tested
Pembrolizumab
Medical subject headings
Sarcoma, Kaposi, Disease Progression

What participants receive

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

  • PembrolizumabDrug

    Route: intravenous infusion Dose regimen: 200 mg per infusion every 3 weeks Duration of treatment: 6 months (8 cycles)

Study groups in NCT03469804
Study groupRoleWhat they receive
PembrolizumabExperimentalPembrolizumab Route: intravenous infusion Dose regimen: 200 mg per infusion every 3 weeks Duration of treatment: 6 months (8 cycles)
Receives: Drug: Pembrolizumab

What is being measured

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

  1. Best Overall Response Rate (BORR)

    Best Overall Response Rate (BORR) defined by the occurrence of complete response or partial response following AIDS Clinical Trials Group (ACTG) criteria recorded from the start of treatment until 6 months or the beginning of any other specific systemic therapy for KS if it occurs before 6 months

    Measured: 6 months

Secondary outcomes (13)

  1. Best overall response rate according to Physical Global Assessment (PGA)

    Best overall response rate according to Physical Global Assessment (PGA) score until 6 months or the beginning of any other specific systemic therapy for KS if it occurs before 6 months

    Measured: 6 months

  2. Response rate according to ACTG and PGA criteria

    Measured: 3 months

  3. Response rate according to ACTG and PGA criteria

    Measured: 6 months

  4. Response rate on number of lesions

    Response rate on number of lesions and at best response as defined following ACTG criteria

    Measured: 3 months

  5. Response rate on number of lesions

    Response rate on number of lesions and at best response as defined following ACTG criteria

    Measured: 6 months

  6. Response rate on the size of target lesions

    Response rate on the size of target lesions and at best response as defined following ACTG criteria

    Measured: 3 months

  7. Response rate on the size of target lesions

    Response rate on the size of target lesions and at best response as defined following ACTG criteria

    Measured: 6 months

  8. Response rate on tumor infiltration of target lesions

    Response rate on tumor infiltration of target lesions and at best response as defined following ACTG criteria

    Measured: 3 months

  9. Response rate on tumor infiltration of target lesions

    Response rate on tumor infiltration of target lesions and at best response as defined following ACTG criteria

    Measured: 6 months

  10. Response rate on lymphedema

    Response rate on lymphedema (circumference, scale of 0 (absence) to 3 (painful or oozing)) at Month 3, Month 6 and at best response as defined following ACTG criteria

    Measured: 3 months

  11. Response rate on lymphedema

    Response rate on lymphedema (circumference, scale of 0 (absence) to 3 (painful or oozing)) at Month 3, Month 6 and at best response as defined following ACTG criteria

    Measured: 6 months

  12. Time to response

    Time to response defined as the time to first response recorded from the start of treatment

    Measured: 6 months

  13. Time to progression

    Measured: 6 months

Timeline

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

  1. First posted19 Mar 2018
  2. Study start1 Jul 2018
  3. Primary completion20 Mar 2020 (estimated)
  4. Study completion20 Sep 2020 (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
Model description
2-stage phase II Simon's Optimal Design
Masking
None (open label)
Enrolment
17 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03469804
Sponsor's protocol ID
P160601
Other IDs
2016-003714-27, 2016
Acronym
KAPKEY
Status last verified
Oct 2019
First submitted
12 Mar 2018
Last updated
21 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Delyon J, Biard L, Renaud M, Resche-Rigon M, Le Goff J, Dalle S, Heidelberger V, Da Meda L, Toullec L, Carcelain G, Mourah S, Caillat-Zucman S, Allain V, Battistella M, Lebbe C. PD-1 blockade with pembrolizumab in classic or endemic Kaposi's sarcoma: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2022 Apr;23(4):491-500. doi: 10.1016/S1470-2045(22)00097-3. Epub 2022 Mar 10.

    PubMed 35279271

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Kaposi Sarcoma and Progression, Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 13 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

Results are not available in the source record.

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

Contact Celeste LEBBE, MD PhD (142499590 ext. +33, celeste.lebbe@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Overall Response Rate (BORR) (time frame: 6 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 NCT03469804, which also lists 1 linked publication.

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 21 Oct 2019.

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