Summary:
Is your advanced bladder
cancer not responding
to treatment?
Learn more about the FIERCE-21 study -
a clinical research study for those
wanting to try another option.
What is the FIERCE-21 study?
The FIERCE-21 study is a clinical research study that will
test the effectiveness and safety of an experimental
drug known as vofatamab. The goal is to determine
how well vofatamab treats advanced bladder cancer
and what effects, good and/or bad, it has on study
participants and their cancer.
Who can participate in the study?
You may be able to join the FIERCE-21 study if you meet
these criteria:*
- Advanced bladder cancer (urothelial carcinoma or
transitional cell carcinoma)
- Cancer that has returned after treatment with
standard therapy or has gotten worse while on
treatment with standard therapy
- FGFR3 mutation and/or fusion positive tumor
*Other criteria will apply
FGFR3 mutation and/or fusion positive status is
determined by completing a tumor profile and/
or comprehensive cancer genetic test. Testing to
determine your FGFR3 status is being offered for
patients who meet study eligibility criteria and have not
previously received this testing.
What is the experimental drug?
The experimental drug (vofatamab) is an intravenous
(IV) drug given by infusion. It is considered
“experimental” because it has not been approved by
the US Food and Drug Administration (FDA), European
Medicines Agency, or any other Regulatory Authority
worldwide for treating cancer or any other disease.
Vofatamab is designed to bind to and slow down the
mutated forms of gene FGFR3 to stop tumor cell growth
and start the death of the cancerous cells.
What will happen if you join the study?
If you join this study, your participation may last up
to 36 months. You will receive one of three possible
treatments:
- Vofatamab alone
- Vofatamab + docetaxel (another type of anti-cancer
drug already available to all patients)
- Placebo (no active ingredients) + docetaxel
This study also has three phases: Phase 1b, Phase 2, and
Phase 2b. Phase 1b and Phase 2 are closed for enrollment.
- Phase 1b has approximately 20 subjects receiving
vofatamab + docetaxel.
- Phase 2 has approximately 40 subjects in 2 different
groups. 20 subjects receive vofatamab + docetaxel,
and 20 subjects receive vofatamab only.
- Phase 2b will have an expansion group and a
randomized group. The expansion group will
have approximately 80 subjects. You will receive
vofatamab only. The randomized group will have
about 160 subjects. You will be randomly assigned to
receive vofatamab + docetaxel or placebo + docetaxel
until your disease progresses, your study doctor
recommends you stop treatment, or you withdraw
your consent for the study. The chance of receiving
vofatamab is 2 times the chance of receiving placebo.
At each visit, study doctors and staff will monitor your
condition, measure vital signs, and collect urine and
blood samples. You can also expect an initial tumor
biopsy and several tumor x-rays or scans.
Information learned from this study may help
researchers understand the effect of the experimental drug on advanced bladder cancer and develop further treatment options for other patients with this type of cancer in the future.