Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFF… (NCT07576725) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial
Uganda50 participantsStarted 2026-09-01
Plain-language summary
This phase II trial studies how well low dose, reduced frequency nivolumab works in treating patients with cancer that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Nivolumab is a type of immune checkpoint inhibitor (ICI). ICIs have revolutionized the treatment of numerous cancers with remarkable improvement in participant outcomes. However, accessibility of ICIs is extremely poor on a global scale, mainly due to high costs. Previous research has suggested that these drugs can be given at lower doses and reduced frequency than their approved dosing regimens, with similar results. Giving nivolumab at a lower dose and less often may help reduce the cost of therapy, improve immunotherapy accessibility, and therefore improve survival outcomes globally.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants are eligible if they have one of these histologically confirmed, unresectable or metastatic cancer types listed below, based upon historical responsiveness to anti-PD-(L)1 agents
* Non-small cell lung cancer (NSCLC) with documented PD-L1 expression (combined positive score \[CPS\] ≥ 1) (NOTE: Participants with known driver oncogenic mutations/rearrangements, including EGFR, ALK and ROS-1, will be excluded.)
* Head and neck squamous cell carcinoma (HNSCC) with documented PD-L1 expression (CPS ≥ 1)
* Clear cell renal cell carcinoma (ccRCC) (NOTE: Other subtypes may be permitted after approval by the Medical Monitor)
* Melanoma (cutaneous, acral-lentiginous and mucosal subtypes), and non-melanoma skin cancers, (cutaneous squamous cell carcinoma \[CSCC\], basal cell carcinoma \[BCC\] and Merkel cell carcinoma \[MCC\])
* Hodgkin's lymphoma
* Urothelial carcinoma
* Cervical cancer with documented PD-L1 expression (CPS ≥ 1)
* Colorectal cancer with high microsatellite instability (MSI) or mismatch repair deficiency
* Kaposi sarcoma (KS) without clinical concern for multicentric Castleman's disease (MCD)
* Any cancer type with historical data suggesting an ORR \> 20% with anti-PD(L)-1 agents (NOTE: All participants in this category must be approved by the Medical Monitor prior to enrollment.)
* Must have experienced disease progression after or deemed not to be a good candidate for available curative systemic therapy options
* …
What they're measuring
1
Objective response
Timeframe: Up to 4 years after completion of study treatment