Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

  • STATUS
    Recruiting
  • End date
    Oct 27, 2024
  • participants needed
    300
  • sponsor
    Incyte Corporation
Updated on 29 July 2021
Investigator
Incyte Corporation Call Center
Primary Contact
I.R.C.C.S. Casa Sollievo della Sofferenza (0.0 mi away) Contact
+83 other location

Summary

This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.

Description


Details
Condition Squamous Cell Carcinoma of the Anal Canal
Treatment carboplatin, Paclitaxel, Retifanlimab
Clinical Study IdentifierNCT04472429
SponsorIncyte Corporation
Last Modified on29 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to comprehend and willing to sign a written ICF for the study
Are 18 years of age or older (or as applicable per local country requirements)
Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC
No prior systemic therapy other than the following: a. Chemotherapy administered concomitantly with radiotherapy as a radiosensitizing agent is permitted. b. Prior neoadjuvant or adjuvant therapy if completed 6 months before study entry
Has measurable disease per RECIST v1.1 as determined by local site investigator/radiology assessment. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion
Able and willing to provide adequate tissue sample and whole blood sample with central testing result prior to randomization. Biopsy for archival samples should have occurred within 6 months prior to randomization
ECOG performance status 0 to 1
If HIV-positive, then must be stable as defined by: a. CD4+ count 300/L, b. Undetectable viral load per standard of care assay, c. Receiving antiretroviral therapy (ART/HAART) for at least 4 weeks prior to study enrollment, and have not experienced any HIV-related opportunistic infection for at least 4 weeks prior to study enrollment
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Has received prior PD-(L)1 directed therapy
Has received prior radiotherapy with or without radiosensitizing chemotherapy within 28 days of Cycle 1 Day 1 (note: all toxicities associated should have resolved to Grade 1)
Participants with laboratory outside of the protocol defined ranges
History of second malignancy within 3 years (with exceptions)
Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders
Active bacterial, fungal, or viral infections, including hepatitis A, B, and C
Receipt of a live vaccine within 28 days of planned start of study therapy
History of organ transplant, including allogeneic stem cell transplantation
Known active CNS metastases and/or carcinomatous meningitis
Known hypersensitivity to platinum, paclitaxel, another monoclonal antibody, or any of the excipients that cannot be controlled with standard measures (eg, antihistamines, corticosteroids)
Participant is pregnant or breastfeeding
Current use of protocol defined prohibited medication
Has pre-existing peripheral neuropathy that is Grade 2 by CTCAE v5
Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note