A Randomised, Double-blind, Placebo-controlled, Phase I/II Trial of RNActive®-derived Cancer Vaccine (CV9104) in Asymptomatic or Minimally Symptomatic Patients with Metastatic Castrate-refractory Prostate Cancer

CureVac AG0 sites200 target enrollmentMarch 1, 2012

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: CureVac AG
Enrollment: 200
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 1, 2012

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

CureVac AG

Eligibility Criteria

Inclusion Criteria

•1\. Male, age \=18 years
•2\. Histologically confirmed castrate\-refractory metastatic adenocarcinoma of the prostate with progressive disease
•\- after surgical castration; or during androgen suppression therapy, including a gonadoptropinreleasing hormone (GNRH) agonist or antagonist
•\- after at least 1 second\-line anti\-hormonal manipulation (e.g. antiandrogen; including combined androgen blockade followed by antiandrogen withdrawal)
•\- a serum testosterone level of \< 50 ng/dL or \< 1\.7 nmol/L.
•Progression will be confirmed either
•\- radiologically (nodal or other soft tissue progression, appearance of 2 or more new lesions on bone scan \- to be confirmed by other imaging if flare or trauma is suspected); or
•\- by 2 consecutive rises of PSA, measured at least 1 week apart, resulting at least in a 50% increase over the nadir and PSA \> 2 ng/mL.
•The last of these PSA values must have been measured within 2 months prior to start of screening and
•\- In patients having received initial combined androgen blockade or have shown a decline in PSA for \=3 months after administration of an antiandrogen an antiandrogen withdrawal response must have been excluded after discontinuation of antiandrogen therapy (e.g. bicalutamide, flutamide or nilutamide) for at least 6 weeks prior to randomisation. Patients with a confirmed progression (PCWG2\) after an antiandrogen withdrawal response are eligible. All patients must have discontinued antiandrogen treatment prior to randomization

Exclusion Criteria

•1\. Previous immunotherapy for PCA (e.g. sipuleucel\-T \[Provenge®], experimental cancer vaccines or ipilimumab \[Yervoy®]).
•2\. Estimated life expectancy of \< 6 months due to PCA or concomitant disease.
•3\. Treatment with any investigational anticancer agents within 4 weeks or 5 half\-lives according to what gives the longer range prior to first dose of study drug.
•4\. Acute pathologic fracture or spinal cord compression at screening.
•5\. Systemic immunosuppressive agents including systemic steroids or immunomodulating agents including herbal remedies (e.g. mistletoe extract) for the previous 28 days prior to the start of treatment or need for such immunosuppressive/\-modulating treatment, except glucocorticoid replacement therapy for adrenal insufficiency. For other conditions where steroid therapy is allowed, see section on prior and concomitant therapy (Section 6\.3\).
•6\. Active skin disease (atopic eczema, psoriasis) in the areas for vaccine injection (upper arms or thighs) preventing the administration of i.d. injections into areas of healthy skin.
•7\. Concurrent major surgery or planned surgery.
•8\. Prior splenectomy or prior allogeneic bone marrow transplant.
•9\. History of or current autoimmune disorders such as sarcoidosis, lupus erythematosus, rheumatoid arthritis, glomerulonephritis systemic vasculitis, autoimmune hepatitis, Sjögren syndrome, scleroderma, polymyalgia rheumatica, arteriitis temporalis, calcinosis, Raynauds
•disease, esophageal dysmotility, sclerodactyly and telangiectasia (CREST) syndrome (limited cutaneous scleroderma), dermatomyositis, Morbus Crohn and colitis ulcerosa except autoimmune thyroiditis with only thyroid hormone replacement or vitiligo or Diabetes Mellitus type 1\.