FMT and anti-PD-1 reinduction in refractory melanoma, Israel
42 stool samples from a phase I intervention trial in Ramat Gan, Israel, testing fecal microbiota transplantation combined with anti-PD-1 immunotherapy reinduction in anti-PD-1-refractory metastatic melanoma patients. machine-written summary
42 samples · 42 runs · IL · Age unknown · 2021 · 4.73 Gbp / sample · cohort Dietary fiber and probiotics influence the gut mic
Checked this project's papers and archive records yourself? Mark it human-verified.
what each source gave
| ✓ Sequence archive | 334 sample values (collection date, country, latitude, location locality, location region, longitude, subject id, timepoint) |
| ○ Abstract / description | read; no usable statement |
| ○ Full text | read; no usable statement or table · PMC10134792, PMC10400536, PMC10799412, PMC10917649, PMC11629153, PMC12180181, PMC12439585, PMC13173278, PMC8454007, PMC8970537 |
| ✓ Supplementary tables | 69 sample values (health condition, health condition detail, intervention) |
| – External resources | not covered by the external resources we ingest |
| – User contribution | nothing uploaded yet |
| – Human verified | not yet checked by a person · I checked this project — verify it |
intervention — arms not resolved
Faecal microbiota transplantation design single_arm_before_after · population other_cancer · FMT with anti-PD-1 re-induction in refractory metastatic melanoma, phase I trial
“phase I clinical trial to assess the safety and feasibility of fecal” — bioproject.description (study level; per-sample arms are in the intervention column below)
longitudinal — not resolvedFMT donor → recipient — not resolved
10 of 12 people sampled more than once (40 samples; median 4, up to 4 per person).
Genera, mean relative abundance over 39 profiled gut samples of this project (Sandpiper SingleM profiles, GTDB R232; low-depth and non-metagenome profiles left out).
| field | samples | coverage | R1 | R2 | R3 | R4 |
|---|---|---|---|---|---|---|
| age_category | 0 | 0% | ||||
| country | 42 | 100% | 42 | |||
| health_condition | 23 | 55% | 23 | |||
| subject_id | 42 | 100% | 42 | |||
| collection_date | 42 | 100% | 42 | |||
| detailed_location | 42 | 100% | ||||
| latitude | 42 | 100% | 42 | |||
| location_locality | 42 | 100% | 42 | |||
| location_region | 42 | 100% | 42 | |||
| longitude | 42 | 100% | 42 | |||
| timepoint_label | 40 | 95% | 40 | |||
| health_condition_detail | 23 | 55% | 23 | |||
| intervention | 23 | 55% | 23 |
- Incongruence between dominant commensal donor microbes in recipient feces post fecal transplant and response to anti-PD-1 immunotherapy. 2021 PMID 34544375 PMC8454007 unsure
- Dietary fiber and probiotics influence the gut microbiome and melanoma immunotherapy response. 2021 PMID 34941392 PMC8970537 unsure
- Consistent Stool Metagenomic Biomarkers Associated with the Response To Melanoma Immunotherapy. 2023 PMID 36809182 PMC10134792 unsure
- Donor-recipient specificity and age-dependency in fecal microbiota therapy and probiotic resolution of gastrointestinal symptoms. 2023 PMID 37537181 PMC10400536 unsure
- Gut microbiome for predicting immune checkpoint blockade-associated adverse events. 2024 PMID 38243343 PMC10799412 unsure
5 more
- Systemic metabolic depletion of gut microbiome undermines responsiveness to melanoma immunotherapy. 2024 PMID 38448159 PMC10917649
- Longitudinal analysis of the gut microbiota during anti-PD-1 therapy reveals stable microbial features of response in melanoma patients. 2024 PMID 39481388 PMC11629153
- Engrafting gut bacteriophages have potential to modulate microbial metabolism in fecal microbiota transplantation. 2025 PMID 40542451 PMC12180181
- Live biotherapeutic <i>enterococcus lactis</i> MNC-168 promotes the efficacy of immune checkpoint blockade in cancer therapy by activating STING pathway via bacterial membrane vesicles. 2025 PMID 40937720 PMC12439585
- Ecological and Functional Stratification of the Stool Microbiome Predicts Response to Immune Checkpoint Inhibitors across Cancer Types. 2026 PMID 42146906 PMC13173278
Archive description
The gut microbiome has been shown to influence the response of tumors to anti-PD-1 immunotherapy in pre-clinical mouse models and observational patient cohorts. However, modulation of gut microbiota in cancer patients has not been investigated in clinical trials. Here we performed a phase I clinical trial to assess the safety and feasibility of fecal microbiota transplantation (FMT) and re-induction of anti-PD-1 immunotherapy in ten patients with anti-PD-1-refractory metastatic melanoma. We observed clinical responses in three patients, including two partial responses and one complete response. Notably, treatment with FMT was associated with favorable changes in immune cell infiltrates and gene expression profiles in both the gut lamina propria and the tumor microenvironment. Together, these early findings have important implications for modulating the gut microbiota in cancer treatment.
How this project entered the registry
Classified as human gut / stool shotgun DNA metagenome of age unknown by opus_adjudicated with confidence 0.75. Assay shotgun_dna.
- host run.host_tax_id · “9606”
- body site study.title · “Fecal microbiota transplantation”
Evidence examples (one per field × route)
| sample | field | value | route | conf. | source | quote |
|---|---|---|---|---|---|---|
| SAMN16811185 | collection_date | 2018-06/2019-06 | R1 | 0.90 | biosample.attribute:collection_date | 2018-06/2019-06 |
| SAMN16811185 | country | IL | R1 | 0.90 | sample.attr.geo_loc_name | Israel: Ramat Gan |
| SAMN16811188 | health_condition | other_cancer | R2 | 0.80 | paper.supp.Table.S1.csv[!Tumor] | Melonoma |
| SAMN16811188 | health_condition_detail | Melonoma | R2 | 0.80 | paper.supp.Table.S1.csv[!Tumor] | Melonoma |
| SAMN16811188 | intervention | drug_therapy | R2 | 0.80 | paper.supp.Table.S1.csv[!Treatment] | anti-CTLA-4 |
| SAMN16811185 | latitude | 32.0467 | R1 | 0.90 | biosample.attribute:lat_lon | 32.0467 N 34.8429 E |
| SAMN16811185 | location_locality | Ramat Gan | R1 | 0.85 | biosample.attribute:geo_loc_name | Israel: Ramat Gan |
| SAMN16811185 | location_region | Tel Aviv | R1 | 0.60 | biosample.attribute:lat_lon | 32.0467 N 34.8429 E |
| SAMN16811185 | longitude | 34.8429 | R1 | 0.90 | biosample.attribute:lat_lon | 32.0467 N 34.8429 E |
| SAMN16811185 | subject_id | Donor1 | R1 | 0.70 | sample.name_rule:alias | Donor1 |
| SAMN16811187 | timepoint_label | 0 | R1 | 0.70 | sample.name_rule:alias | R10-0 |
Sequencing
42 runs over 42 samples · mean 5.29 Gbp per run (median 4.73 Gbp, total 222.32 Gbp; 42 runs with a base count) · layout PAIRED 42 · platform ILLUMINA 42 · models HiSeq X Ten (42) · 93% of runs with a Sandpiper profile · first public 2021-01-20
Authors (56)
Hu M first · Lin X · Sun T · Shao X · Huang X · Du W · Guo M · Zhu X · Zhou Y · Tong T · Guo F · Han T · Wu X · Shi Y · Xiao X · Zhang Y · Hong J · Chen H last · Zakharevich NV first · Morozov MD · Kanaeva VA · Filippov MS · Zyubko TI · Ivanov AB · Ulyantsev VI · Klimina KM · Olekhnovich EI last · Ji S first · Ahmad F · Peng B · Yang Y · Su M · Zhao X · Vatanen T last · Xian Y first · Chen Z · Lan Z · Zhang C · Sun H · Liu Z · Kong P · Liang Y · Zhao Y · Liu SM · Gan L · Li B · Su X · Huang B · Xiao C · Zhu R · Zhao G · Lao C · Lin CS · Zhang D · Jiang X last · Orletskaia VA first
Downloads
PRJNA678737.csv.gz (2.0 KB) · parquet (71.8 KB) — all 42 samples, every field with route and confidence · PRJNA678737_determinations.csv.gz (3.3 KB) — 403 evidence rows