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Breast CancerPhase 1PROLOGNCT02914470

Carboplatin-cyclophosphamide Combined With Atezolizumab

A Phase 1 study testing carbplatin, cyclophophamide, atezolizumab in people with Breast Cancer and Cervix Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.

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 single centre, 3+3, dose finding, open label, phase 1b clinical study of carboplatin and cyclophosphamide, in combination with atezolizumab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Cervix Cancer, Ovarian Cancer
What is being tested?
carbplatin, cyclophophamide, atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteNetherlands
Study dates
Jan 2017to Oct 2021
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological proof of advanced breast cancer (M1) or advanced gynaecological cancer (cervix (M1, FIGO IVA/IVB), ovarian (only after recurrence on carboplatin and/or paclitaxel) stage 4 cervical or endometrial (T3-T4, FIGO IVA/IVB) cancer) pre-treated with maximally one line of systemic chemotherapy in the advanced setting and any line of hormonal therapy for advanced disease and potentially benefitting from carboplatin-cyclophosphamide and atezolizumab. (prior (neo-)adjuvant chemotherapy is accepted and does not count as one line, since administered in early stage disease);
  • Men and women >= 18 years;
  • Able and willing to give written informed consent;
  • WHO performance status of 0 or 1;
  • Life expectancy >= 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;
  • Minimal acceptable safety laboratory values

Who cannot join

  • Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or 21 days for standard (neo-)adjuvant chemotherapy, hormonal and immunotherapy;
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease;
  • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
  • Women who have a positive pregnancy test (urine or serum) and/or who ware breast feeding;
  • Unreliable contraceptive methods. Women and men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: oral, injected or implanted hormonal methods, intra-uterine devices or systems, condom or other barrier contraceptive measures, sterilization and true abstinence);
  • Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
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  • Positive test for HIV
  • Active hepatitis B (defined as having a positive hepatitis B surface antigen [HbsAg] test at screening) or active hepatitis C Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible.
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RN
  • Active tuberculosis
  • Receipt of a live, attenuated vaccine within 28 days prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4 (like Ipilimumab), anti-PD-1 (like pemprolizumab), or anti-PD-L1 therapeutic antibodies (like atezolizumab).
  • Treatment with systemic immunostimulatory agents (including but not limited to interferons or IL-2) within 28 days or five half-lives of the drug (whichever is shorter) prior to enrolment;
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 28 days prior to enrolment, or anticipated requirement for systemic immunosuppressive medications during the trial
  • Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., one-time dose of dexamethasone for nausea) may be enrolled in the study. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed;
  • Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;
  • Recent myocardial infarction (<six months prior to enrolment) or unstable angina;
  • New York Heart Association Class II or greater congestive heart failure. If cardiac failure is suspected: LVEF by MUGA or ultrasound must be ≥ 50% and should be performed within 28 days prior to enrolment.
  • Symptomatic brain metastases. If adequately treated with resection and/or irradiation and patients are at least four weeks completely free of symptoms of these metastases and without medication related to these metastases patients could be eligible if all other in-and exclusion criteria are obeyed.
  • Known leptomeningeal metastases; History of autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, imflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis; Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study;
  • Prior allogenic stem cell or solid organ transplantation;
  • History of idiopathic pulmonary fibrosis (including bronchiolitis obliterans with organizing pneumonia) or evidence of active pneumonitis on screening chest computed tomography scan.
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Severe infections within 28 days prior to enrolment, including, but not limited to, hospitalization for complications of infection, bacteraemia, or severe pneumonia;
  • Signs or symptoms of significant infection within 2 weeks prior to enrolment;
  • Received oral or IV antibiotics within 2 weeks prior to enrolment
  • Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible;
  • History of stroke or transient ischemic attack (TIA) within 6 months prior to enrolment;
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrolment or anticipation of need for major surgical procedure during the course of the study
  • Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Antoni van Leeuwenhoek

    Amsterdam

Other trials in Netherlands

About this study

Official title: A Phase 1b to Assess the Safety and Tolerability of Carboplatin-cyclophosphamide Combined With Atezolizumab, an Antibody That Targets Programmed Death Ligand 1 (PD-L1), in Patients With Advanced Breast Cancer and Gynaecologic Cancer

This is a single centre, 3+3, dose finding, open label, phase 1b clinical study of carboplatin and cyclophosphamide, in combination with atezolizumab.

Read the detailed description

The starting dose is carboplatin AUC 5mg/ml*min, cyclophosphamide 600mg/m2 and atezolizumab 840 mg, all administered intravenously. One cycle is 28 days. On day 1 carboplatin, cyclophosphamide and atezolizumab will be administered. On day 15 atezolizumab only will be administered. Patients will be treated until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. It is expected that 6-12 patients will be enrolled, depending on safety issues observed.

Being tested
carbplatin, cyclophophamide, atezolizumab
Keywords
advanced
Medical subject headings
Breast Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms

What participants receive

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

  • carbplatin, cyclophophamide, atezolizumabDrug

Study groups in NCT02914470
Study groupRoleWhat they receive
carbo, cyclo, atezolizumabExperimentalThe starting dose is carboplatin AUC 5mg/ml*min (d1), cyclophosphamide 600mg/m2(d1) and atezolizumab 840 mg (D1, 15), all administered intravenously
Receives: Drug: carbplatin, cyclophophamide, atezolizumab

What is being measured

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

  1. Toxicity; Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03

    Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03

    Measured: up to 30 days after end of treatment

Secondary outcomes (1)

  1. Overall Response Rate

    Tumor response will be measured according to the RECIST 1.1 criteria

    Measured: assessed up to 120 months

Timeline

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

  1. First posted26 Sep 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionAug 2017
  4. Study completionOct 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02914470
Sponsor's protocol ID
N16LOG
Acronym
PROLOG
Status last verified
Oct 2021
First submitted
6 Sep 2016
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: to be determined

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing carbplatin, cyclophophamide, atezolizumab in people with Breast Cancer and Cervix Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.

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 30 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 19 Oct 2021. 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 Netherlands. 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?

Toxicity; Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03 (time frame: up to 30 days after end of treatment). 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 NCT02914470.

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 19 Oct 2021.

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