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Gynecologic CancerPhase 1NCT02459301

A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies

A Phase 1 study testing IPH2201 in people with Gynecologic Cancer, run by Canadian Cancer Trials Group at 7 sites in Canada.

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

The purpose of this study is to test the safety of a new drug, IPH2201, to see what effects it has on this type of cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gynecologic Cancer
What is being tested?
IPH2201
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
7 sitesCanada
Study dates
17 Sep 2015to 12 Nov 2019
Phase
Phase 1
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

  • Patients must have a histologically and/or cytologically confirmed gynecologic malignancy including high-grade serous ovarian/fallopian tube or peritoneal carcinoma, cervical cancer (squamous cell carcinoma) or endometrial cancer (adenocarcinoma), that is advanced/metastatic/recurrent or unresectable and for which no curative therapy exists.
  • For patients with HGSC: For Part 2 of this study, patients will be classified as either platinum resistant or platinum sensitive, as defined by their previous response to platinum-based therapy:
  • The platinum resistant cohort will include patients with disease progression within 6 months of the last line of platinum-based therapy dose.
  • The platinum sensitive cohort will be defined by progression 6 months or longer since last platinum-based therapy dose.
  • All patients must have an available formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) and must have provided informed consent for the release of the block (or slides), as well as for samples for correlative studies and banking.
  • At least 4 patients registered to each cohort in Part 2 must also have provided informed consent for and be willing to undergo a tumour biopsy prior to treatment (after registration) and after treatment with IPH2201. Note: During accrual to Part 2, it may be necessary to restrict accrual to patients who are suitable for, and have consented to, tumour biopsy before and after treatment.
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  • Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to randomization/registration (within 35 days if negative).
  • All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows:
  • Chest x-ray ≥ 20 mm CT scan (with slice thickness of 5 mm) ≥ 10 mm --> longest diameter Physical exam (using calipers) ≥ 10 mm Lymph nodes by CT scan ≥ 15 mm --> measured in short axis
  • Patients must be ≥ 18 years of age.
  • Patients must have an ECOG performance status of 0, 1, or 2.
  • Previous Therapy
  • Cytotoxic Chemotherapy: All patients must have received at least one prior regimen of chemotherapy for advanced, metastatic, or recurrent disease, one of which must have been platinum-based. Patients may have received no more than 3 prior regimens.
  • Other systemic therapy: All patients may have received other therapies including immunotherapy, angiogenesis inhibitors, PARP inhibitors or signal transduction inhibitors.
  • Patients must have recovered from all reversible toxicity related to prior chemotherapy or systemic therapy and have adequate washout as follows:
  • Longest of one of the following:
  • Two weeks
  • 5 half lives for investigational agents
  • Standard cycle length of standard therapies
  • Radiation: Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of randomization/registration. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with NCIC CTG.
  • Surgery: Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of randomization/registration, and that wound healing has occurred.
  • Patients must have recovered from any treatment related toxicities prior to randomization/registration (unless grade 1, irreversible, or considered by investigator as not clinically significant).
  • Absolute neutrophils ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Bilirubin ≤ 1.5 x ULN (upper limit of normal)
  • AST and ALT ≤ 2.5 x ULN
  • Serum creatinine < 1.25 x ULN ; ≤ 5.0 x UNL if patient has known liver metastases
  • Women of childbearing potential must have agreed to use a highly effective contraceptive method during the study and for up to 5 months after the last dose of IPH2201.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to randomization/registration in the trial and prior to tests which are considered to be study specific to document their willingness to participate.
  • Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.
  • Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, response assessment, adverse events, and follow-up.
  • In accordance with CCTG policy, protocol treatment is to begin within 5 working days of patient randomization (Part 1) or registration (Part 2).

Who cannot join

  • Patients with a history of other active or current malignancies that require active treatment.
  • Patients with serious illness or medical conditions that might be aggravated by treatment or limit compliance including, but not limited to:
  • History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.
  • Uncontrolled diabetes
  • Active uncontrolled or serious infection (viral, bacterial or fungal)
  • Other medical conditions that might be aggravated by study treatment
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  • Patients with active immune-mediated diseases or known HIV infection or hepatitis B or C.
  • Patients receiving systemic corticosteroid therapy at doses equivalent to more than 5 mg prednisone. Note: Topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are permitted.
  • Patients receiving cytokines and/or growth factors.
  • Patients who have experienced severe adverse effects from other immunotherapy-based treatment or monoclonal antibodies.
  • Patients receiving concurrent treatment with other anti-cancer therapy or investigational agents.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

The purpose of this study is to test the safety of a new drug, IPH2201, to see what effects it has on this type of cancer.

Read the detailed description

This research is being done because there is no treatment that will cure this type of cancer. Although some types of chemotherapy may cause this cancer to shrink for a time, better options are needed. In laboratory tests and animals, IPH2201 has been shown to have effects which result in shrinkage of tumours. IPH2201 has been studied in people with rheumatoid arthritis but it has not yet been studied in people with cancer and the investigators do not know if it can offer better results than standard treatment.

The standard or usual treatment for this disease could include surgery, chemotherapy or radiation.

Being tested
IPH2201

What participants receive

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

  • IPH2201Drug

Study groups in NCT02459301
Study groupRoleWhat they receive
IPH2201ExperimentalPart 1: 1, 4 or 10mg/kg, IV, 1 hour duration on Day 1 every 2 weeks. Part 2: Patients will receive single agent IPH2201 as above with the actual dose dependent on the outcome of Part 1
Receives: Drug: IPH2201

What is being measured

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

  1. Dose of single agent IPH2201 for phase II studies and determined based on toxicity, as well as pharmacokinetic and pharmacodynamics data

    To confirm the recommended phase II dose (RP2D) of single agent IPH2201 in patients with advanced/metastatic/recurrent platinum sensitive or resistant high-grade serous carcinoma (HGSC) of ovarian, fallopian tube or peritoneal origin.

    Measured: 24 months

Secondary outcomes (4)

  1. Number and severity of adverse events in patients

    • Safety and tolerability of IPH2201

    Measured: 24 months

  2. Correlative assays evaluation for potential predictive markers of IPH2201 effects. Concentration at the end of administration (Cinf end) for all patients

    Correlative assays will be used to evaluate potential predictive markers of IPH2201 effects. Other potential prognostic or predictive molecular factors will be assesses in archival tumour tissue, CTCs and blood samples.

    Measured: 24 months

  3. Area under the curve from time 0 to Tau=2 weeks (AUC(0-Tau)

    Measured: 24 months

  4. Accumulation ratio, in terms of Cmax and AUC(0-Tau), between C1 and C4

    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 posted2 Jun 2015 (estimated)
  2. Study start17 Sep 2015
  3. Primary completion15 Nov 2017
  4. Study completion12 Nov 2019

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 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02459301
Sponsor's protocol ID
I221
Status last verified
Apr 2020
First submitted
19 May 2015
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tinker AV, Hirte HW, Provencher D, Butler M, Ritter H, Tu D, Azim HA Jr, Paralejas P, Grenier N, Hahn SA, Ramsahai J, Seymour L. Dose-Ranging and Cohort-Expansion Study of Monalizumab (IPH2201) in Patients with Advanced Gynecologic Malignancies: A Trial of the Canadian Cancer Trials Group (CCTG): IND221. Clin Cancer Res. 2019 Oct 15;25(20):6052-6060. doi: 10.1158/1078-0432.CCR-19-0298. Epub 2019 Jul 15.

    PubMed 31308062

  • Roberto A, Di Vito C, Zaghi E, Mazza EMC, Capucetti A, Calvi M, Tentorio P, Zanon V, Sarina B, Mariotti J, Bramanti S, Tenedini E, Tagliafico E, Bicciato S, Santoro A, Roederer M, Marcenaro E, Castagna L, Lugli E, Mavilio D. The early expansion of anergic NKG2Apos/CD56dim/CD16neg natural killer represents a therapeutic target in haploidentical hematopoietic stem cell transplantation. Haematologica. 2018 Aug;103(8):1390-1402. doi: 10.3324/haematol.2017.186619. Epub 2018 Apr 26.

    PubMed 29700172

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IPH2201 in people with Gynecologic Cancer, run by Canadian Cancer Trials Group at 7 sites in Canada.

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 32 inclusion and 11 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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Dose of single agent IPH2201 for phase II studies and determined based on toxicity, as well as pharmacokinetic and pharmacodynamics data (time frame: 24 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 NCT02459301, which also lists 2 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 4 Aug 2023.

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